Medical Device Document Selector: Find Documents by Task
Start with the work you need to complete. Expand a task below to see relevant documents, the role each plays and a practical guide. This free selector covers all 112 products in the A.P. Lyon catalog; some documents appear under more than one task.
How to choose
Identify the gap in your existing documentation first. Choose an individual document for a specific gap, a bundle for connected gaps, or a quality-system package when you need a broader foundation. Review the product content list and existing overlaps before purchase. Equipment qualification protocols must match the equipment and study stage.
How to Choose a Medical Device Quality Management System
Choose a quality management system by the activities your organization performs, the responsibilities it retains and the markets it serves. A large document collection can still leave a critical process uncovered; a smaller set can be useful when its boundaries match your business. Start with a process inventory before comparing package names.
ISO 13485 Quality Management System Manual
Use the manual to describe the organization’s QMS scope and its relationship to supporting procedures.
Medical Device Quality Management System | BASE SYSTEM
Compare BASE when assessing a starter documentation foundation that can be expanded as activities grow.
Medical Device Quality Management System | BASE PLUS SYSTEM
Compare BASE PLUS against BASE using the actual content lists and the gaps in your process inventory.
Medical Device Quality Management System | DESIGN PLUS
Consider DESIGN PLUS for research and development organizations, including specification developers that do not manufacture.
Medical Device Quality Management System | MANUFACTURING
Review MANUFACTURING for documentation spanning development, manufacturing and post-commercialization activities.
Medical Device Quality Management System | MANUFACTURING PLUS
Review MANUFACTURING PLUS when comparing the broadest package in this range with the activities you actually perform.
Medical Device Design and Development Procedures
Use the focused design and development collection to strengthen an existing system; it is not a complete standalone QMS.
Medical Device QMS Responsibilities and Management Review
A quality system works more consistently when decisions have named owners. An organization chart shows reporting relationships, but it may not explain who can stop production, approve a change or commit resources to an unresolved problem. Responsibility definitions and management review connect those decisions with evidence.
Organization, Responsibilities, and Authority Procedure
Use the responsibilities and authority procedure to define management and departmental roles, then tailor the assignments to your organization.
Management Review Procedure | ISO 13485 | FDA QMSR
Use the management review procedure and forms to organize inputs, decisions and follow-up records.
Training Procedure | ISO 13485 | FDA QMSR
Connect role assignments with the training process so people receive training appropriate to the work and decisions assigned to them.
Medical Device Document Control: From Approval to Record Retention
Document control is the route by which an approved instruction reaches the people who use it. Record control preserves evidence of what actually happened. Treat the two as connected processes while keeping their different purposes clear: revising a procedure is different from correcting a completed production record.
Engineering Change Notice Procedure | ISO 13485 | FDA QMSR
Use ECN documentation to assess and approve changes, including the disposition of affected materials and work in progress.
Document Control Procedure | ISO 13485 | FDA QMSR
Use document control to govern revision, issuance, document requests and status reporting.
Specification Format Procedure | ISO 13485 | FDA QMSR
Use specification formats to make controlled instructions and records easier to identify and complete consistently.
Good Documentation Practices Procedure | ISO 13485 | FDA QMSR
Use good documentation practices for recording work and making clear, traceable corrections.
External Standards Procedure | ISO 13485 | FDA QMSR
Use external-standard controls to identify revisions and assess their effect on your products and documentation.
Record Retention Procedure | ISO 13485 | FDA QMSR
Use record-retention controls to define preservation, archive responsibilities and retrieval.
ISO 13485 Document Control Procedure Bundle
Compare the document-control bundle when several connected controls need to be established together.
Medical Device Design Controls: Requirements, Reviews and Transfer
Design controls connect a product idea with evidence that the released device meets its requirements and intended use. A practical project structure makes those connections visible throughout development. The aim is a coherent set of decisions and records, not a collection assembled only when a review or submission approaches.
Design Control Procedure | ISO 13485 | FDA QMSR
Use design control for phase planning, responsibilities and development records.
Medical Device Product Performance Specification Procedure
Use the product performance specification procedure to translate customer and clinical needs into measurable technical requirements.
Design Review Procedure | ISO 13485 | FDA QMSR
Use design review for cross-functional assessment, decisions and action follow-up at defined milestones.
Design Verification - Validation Procedure | ISO 13485 | FDA QMSR
Use verification and validation documentation to plan distinct questions and record the evidence answering them.
Design Transfer Procedure | ISO 13485 | FDA QMSR
Use design transfer to connect development outputs with manufacturing readiness.
Use design-change controls to assess proposed changes and their effects before implementation.
Design Analysis Procedure | ISO 13485 | FDA QMSR
Use design analysis when structured analytical methods are needed to examine design or process concerns.
Design Control Procedure Bundle | ISO 13485 | FDA QMSR
Compare the design-control bundle for a coordinated set covering control, review, transfer, verification and validation.
Medical Device Risk Management: Design and Process Risks
Device risk management links hazards, controls and evidence across the product lifecycle. Design and production analyses contribute different perspectives. Keeping their relationship clear helps the team recognize when a manufacturing change affects a device risk or when post-market information calls an earlier assumption into question.
Use the lifecycle risk-management procedure for planning, the risk file, evaluation, controls and ongoing review.
Design Risk Management Procedure
Use design risk management to examine device hazards and the effects of design controls.
Process Risk Management Procedure
Use process risk management to analyze production flow, process failures and associated controls.
Risk Management Procedures Bundle | ISO 13485 | FDA QMSR
Compare the risk-management bundle for coordinated lifecycle, design, process and design-analysis documentation.
Medical Device Usability and Customer Requirements Validation
Customer feedback and usability evaluation answer related but different questions. Customers can tell you whether a product addresses their needs. Human factors work examines how intended users interact with the device and where use errors can lead to harm. A useful plan identifies the question before choosing a study method.
Human Factors and Usability Engineering Procedure
Use human factors and usability engineering documentation for user-interface planning, use-related risks and evaluation activities.
Customer Requirements Validation Procedure
Use customer requirements validation when collecting feedback on a defined configuration and assessing how it meets customer needs.
Medical Device Software: Development, Validation and Clinical Evidence
The word software covers several different documentation needs in a medical device business. Software that is itself a device, software used in production or the QMS, and the clinical evidence behind software claims should not be treated as one interchangeable validation project. Start by defining the software’s intended use and role.
Medical Device Software Development Plan
Use the development plan to assign software lifecycle phases, responsibilities and planned outputs.
Software as a Medical Device (SaMD) Development Procedure
Use the SaMD development procedure for requirements, implementation, verification, release and maintenance controls.
Software Validation Procedure | ISO 13485 | FDA QMSR
Use software validation documentation for systems supporting development, production, inspection and quality activities.
Software Clinical Evaluation Procedure
Use software clinical evaluation to examine evidence supporting the medical software’s clinical claims.
Medical Device Software Procedure Bundle
Compare the software bundle when the project needs coordinated development, validation, usability and clinical-evaluation documents.
Clinical Evaluation Reports: Turning Medical Device Evidence into Conclusions
A clinical evaluation report explains what the available clinical evidence means for a defined device and its claims. It should make the reasoning traceable from the device scope through evidence selection and appraisal to conclusions and remaining gaps. Copying references into a report is not the same as evaluating them.
Use the clinical evaluation procedure and report structure to organize planning, evidence appraisal, analysis and reporting.
Clinical Evaluation Procedure Bundle
Compare the clinical evaluation bundle when coordinated clinical, PMCF, surveillance and investigation documentation is needed.
PMCF Plan vs PMCF Evaluation Report: What Each Document Does
A post-market clinical follow-up plan describes the clinical questions and activities to pursue after marketing. A PMCF evaluation report assesses the completed activities and their findings. Keeping these documents distinct makes it easier to compare what was intended with what actually happened and decide what should change next.
Post-Market Clinical Follow-Up Plan
Use the PMCF plan document to define objectives, methods, sources, responsibilities and timelines.
Post-Market Clinical Follow-Up Evaluation Report
Use the PMCF evaluation report document to assess completed follow-up findings and their implications for the device evidence.
Clinical Investigation Documents: Plan, Investigator Brochure and Report
Clinical investigation documentation serves different readers at different stages. The plan defines the study before it begins, the investigator brochure communicates relevant device information, and the report accounts for the completed investigation. A controlling procedure coordinates responsibilities and conduct across the study.
Clinical Investigation Procedure
Use the clinical investigation procedure to coordinate study planning, conduct, monitoring and close-out.
Medical Device Clinical Investigation Plan (CIP) | ISO 14155:2026
Use the CIP document to define the prospective study design, objectives, endpoints, population and follow-up.
Medical Device Investigator Brochure
Use the standalone investigator brochure for device information, existing evidence, risks and anticipated benefits.
Medical Device Clinical Investigation Report | ISO 14155:2026
Use the investigation report document to present completed methods, results, deviations and analysis.
Medical Device Post-Market Surveillance and PSUR Planning
Post-market surveillance turns information from device use into decisions about safety, performance and the quality system. A periodic safety update report is one reporting output for devices to which the relevant requirement applies. Establish the information flow before choosing the report format.
Post Market Surveillance Procedure
Use the PMS procedure to organize collection, evaluation and links to risk management, clinical evaluation and quality action.
Periodic Safety Update Report (PSUR) Procedure
Use the PSUR procedure and reporting documents when preparing the applicable periodic safety update output.
Medical Device Complaints: Intake, Investigation and Trending
A complaint process should preserve the original report, assess immediate concerns and move the case toward a documented conclusion. Trending examines patterns across cases. Both depend on usable data, but neither should delay an individual safety or reportability assessment while the team waits for a trend to develop.
Complaint Handling Procedure | ISO 13485 | FDA QMSR
Use complaint handling documentation for intake, assessment, investigation, reporting decisions and closure.
Complaint Trending Procedure | ISO 13485 | FDA QMSR
Use complaint trending to organize analysis methods, alert limits and escalation of patterns.
Product Hold Procedure | ISO 13485 | FDA QMSR
Use product hold when affected or potentially affected devices need controlled identification and segregation.
Complaint Handling Procedures Bundle | ISO 13485 | FDA QMSR
Compare the complaint bundle for connected intake, trending, reporting, recall, vigilance and hold controls.
Nonconforming Material, Failure Investigation and CAPA
Containment, disposition, investigation and corrective action are connected decisions with different purposes. A nonconforming-material record controls affected material. A failure investigation examines what happened and why. CAPA addresses the causes and checks whether the chosen action works over time.
Nonconforming Material Procedure | ISO 13485 | FDA QMSR
Use nonconforming-material controls to identify, segregate, review and disposition discrepancies.
Failure Investigation Procedure
Use failure investigation to examine failures against performance specifications and document the supported root cause.
Corrective and Preventive Action Procedure | ISO 13485 | FDA QMSR
Use CAPA documentation for action planning, implementation, effectiveness review and closure.
FDA MDR, EU Vigilance and Medical Device Recall Workflows
An adverse-event report and a field action answer different regulatory and operational questions. FDA Medical Device Reporting, EU vigilance and recall or correction activities can overlap, but one decision does not automatically resolve all the others. Define the markets, responsible roles and escalation route when the information first arrives.
Medical Device Reporting (MDR) Procedure | 21 CFR Part 803
Use FDA MDR documentation for U.S. reportability evaluation, electronic submission and associated records.
Use vigilance documentation for EU serious-incident and field-safety corrective-action assessment.
Remedial Action - Recall Procedure | ISO 13485 | FDA QMSR
Use remedial action and recall documentation for affected distribution, action planning, communication and effectiveness tracking.
Medical Device Supplier Management and Purchase Orders
Supplier approval and purchase-order control serve different parts of the same relationship. Approval assesses whether a supplier is suitable for the intended work. The purchase order communicates what must be supplied for a particular transaction. A supplier can be approved while an individual order still omits an important requirement.
Supplier Management Procedure | ISO 13485 | FDA QMSR
Use supplier management for selection, evaluation, approval and performance monitoring.
Purchase Order Procedure | ISO 13485 | FDA QMSR
Use purchase-order controls for preparing, reviewing and approving orders with the correct requirements.
Medical Device Quality Agreements and Consulting Contracts
An agreement makes responsibility boundaries explicit before a quality issue or commercial dispute tests them. A supplier quality agreement, manufacturer-distributor agreement and consulting agreement govern different relationships. Choose the document by the parties and work involved, then review it against the actual arrangement.
Medical Device Quality Agreement | United States
Use the United States quality agreement when allocating duties between a device company and its supplier for that market.
Medical Device Quality Agreement | Europe
Use the Europe quality agreement when defining manufacturer and distributor responsibilities for the European arrangement.
Use the master consulting agreement as a starting structure for engagement duties and commercial expectations.
ISO 13485 Contract Review Procedure
Use contract-review controls to assess product approvals, pricing, delivery and contractual requirements before commitments are accepted.
Receiving Inspection, First Article Inspection and Lot Acceptance
Incoming material needs both identity and an acceptance decision. Receiving checks establish what arrived and how it relates to purchasing information. First article inspection examines a component against the approved specification. Lot inspection applies an acceptance approach to a defined lot. These activities can connect without being interchangeable.
Receiving and Identification of Materials Procedure
Use receiving controls for delivery checks, receipt records and movement into inspection or inventory.
First Article Inspection Procedure
Use first article inspection for the approved drawing, measured characteristics and inspection report.
Lot Inspection Procedure | ISO 13485 | FDA QMSR
Use lot inspection for sample selection, acceptance criteria and recorded lot decisions.
Identification Procedure | ISO 13485 | FDA QMSR
Use identification controls to distinguish materials and products and display their acceptance status.
Medical Device Production Records, Line Clearance and Shipment
Production documentation connects the approved manufacturing instructions with evidence for an actual work order or lot. Line clearance reduces mix-up risks before work starts, while shipment controls preserve identity and the recorded release decision as product leaves the facility. Returns need their own controlled route back into the system.
Device Master Record and Technical Documentation Procedure
Use the DMR and technical-documentation procedure to organize the controlled manufacturing definition.
Device History Record Procedure
Use the DHR procedure to compile and review records for an actual work order or lot.
Use line clearance to check manufacturing, labeling and packaging areas before the next order.
Finished Goods Handling and Shipment Procedure
Use finished-goods handling and shipment controls for selection, verification, packaging and shipping records.
Use returned-goods controls for authorization, controlled receipt, investigation and recorded disposition.
Equipment IQ, Calibration and Preventive Maintenance
Installation qualification, calibration and preventive maintenance provide different evidence about equipment. IQ establishes that installation requirements have been addressed. Calibration examines measurement performance. Maintenance manages servicing and condition over time. A dependable equipment program connects all three with the equipment’s intended use.
Installation Qualification IQ Procedure | ISO 13485 | FDA QMSR
Use IQ documentation for new, relocated or modified equipment installation and prerequisite checks.
Calibration System Procedure | ISO 13485 | FDA QMSR
Use the calibration system procedure for equipment registration, calibration requirements, status and result assessment.
Preventive Maintenance Procedure
Use preventive maintenance for routine servicing, repairs, inspections and adjustments.
Medical Device Process Validation: Protocols, Statistics and Mold Processes
A process validation program defines the evidence needed to demonstrate that a process can consistently achieve its intended result. The procedure establishes the decision framework; a protocol specifies the study; the report explains actual execution and conclusions. Statistical methods support the evidence when their assumptions fit the question.
Medical Device Process Validation Procedure
Use process validation to organize prerequisites, study selection, acceptance and ongoing review.
Validation Protocol and Report Procedure | ISO 13485 | FDA QMSR
Use the protocol and report procedure to structure planned qualification work and its final account.
Statistical Techniques Procedure | ISO 13485 | FDA QMSR
Use statistical techniques to plan and analyze samples and validation data with justified methods.
Injection Mold Validation Procedure
Use injection-mold validation for tooling development and process evidence relating to critical part dimensions and tolerances.
ISO 13485 Process Validation Procedure Bundle
Compare the process-validation bundle for connected process, IQ, protocol/report and statistical documentation.
Tray Sealer Qualification: OQ vs PQ for Sterile-Barrier Packaging
Tray sealer qualification should address both the proposed operating window and repeated performance under defined production conditions. OQ and PQ answer these different questions. Begin with the actual tray, lid material, equipment and intended sealing configuration; results from a different combination need a justified applicability assessment.
Tray Sealer Operational Qualification Protocol
Use the tray OQ protocol to plan challenges at the proposed sealing-window limits.
Tray Sealer Performance Qualification Protocol
Use the tray PQ protocol to assess repeatable sealing under defined production conditions.
Tray Sealer Qualification Protocol Bundle
Choose the tray qualification bundle when both OQ and PQ documentation are needed together.
Bar Sealer Qualification: Planning Pouch OQ and PQ
A bar sealer qualification study needs a defined relationship among the sealer, pouch materials and operating conditions. A protocol for another equipment type may miss relevant setup or specimen considerations. OQ establishes evidence around the proposed process window; PQ evaluates repeatable production using the selected conditions.
Bar Sealer Operational Qualification Protocol
Use the bar-sealer OQ protocol to plan challenges to proposed process limits.
Bar Sealer Performance Qualification Protocol
Use the bar-sealer PQ protocol to evaluate repeated sealing under defined production conditions.
Bar Sealer Qualification Protocol Bundle
Compare the bar-sealer bundle when a coordinated OQ and PQ set is needed.
Four-Side Seal Pouch Qualification: Sealing Window and Production Evidence
Four-side pouch sealing requires evidence appropriate to the equipment configuration and the complete package. OQ and PQ should preserve information about the sealing conditions and the package areas evaluated. A single favorable result cannot explain whether the proposed window and routine production conditions are adequately supported.
4-Side Seal Pouch Operational Qualification Protocol
Use the four-side pouch OQ protocol for prerequisite checks and sealing-window challenges.
4-Side Seal Pouch Performance Qualification Protocol
Use the four-side pouch PQ protocol for repeated production performance and deviation review.
4-Side Seal Pouch Qualification Protocol Bundle
Compare the four-side qualification bundle for coordinated operational and performance studies.
Medical Device Shelf Life and Accelerated Aging: Define the Claim First
A shelf-life claim can involve device performance, packaging integrity and other attributes that change with time. Accelerated aging of a sterile-barrier package answers a narrower question than the stability of the entire device. Define the claim and the evidence needed for each relevant attribute before selecting aging conditions.
Accelerated Aging Study Protocol
Use the accelerated-aging protocol for sterile-barrier packaging assumptions, exposures, post-aging evaluations and parallel real-time planning.
Product Stability Shelf-Life Procedure | ISO 13485 | FDA QMSR
Use the product stability and shelf-life procedure to organize the broader evidence supporting the device’s shelf-life claim.
Medical Device Cleanrooms: Qualification, Monitoring, Cleaning and Gowning
A qualified cleanroom needs operating controls that preserve its intended condition. Design and qualification define the facility baseline. Environmental monitoring, cleaning and personnel practices manage the ongoing environment. Connect these activities with the product and process risks that the controlled area is intended to address.
Cleanroom Design and Validation Procedure
Use cleanroom design and validation for requirements, design and qualification planning.
Environmental Controls Procedure
Use environmental controls for operating attributes and monitoring of the controlled area.
Controlled Environment Cleaning Procedure | ISO 13485 | FDA QMSR
Use controlled-environment cleaning for methods, schedules, agents and cleaning records.
Controlled Environment Gowning Procedure
Use gowning controls for hygiene, dress and entry practices.
Compare the cleanroom bundle for coordinated design, environmental-control and cleaning documentation; check its content list for scope.
Orthopedic Implant Final Cleaning PQ: From Contamination Risk to Evidence
Final-cleaning performance qualification examines whether the defined manufacturing cleaning process achieves its intended result for orthopedic implants. Start with the contamination risks, product families and process conditions. A useful study connects each acceptance decision with a justified method and traceable samples.
Performance Qualification Protocol | Orthopedic Implant Final Cleaning
Use the orthopedic implant final-cleaning PQ protocol to connect contamination risk, cleaning-family selection, methods and acceptance decisions.
Medical Device Biological Evaluation: Materials, Contact and Evidence Gaps
Biological evaluation asks whether the device’s contact with the body can produce an unacceptable biological response. Begin with the finished device, its materials and processing, and the nature of contact. A risk-based evidence assessment helps identify what existing information can support and where further evaluation is needed.
Biocompatibility - Toxicity Testing Procedure | ISO 13485 | FDA QMSR
Use the biocompatibility and toxicity-testing procedure to organize materials, patient contact, existing evidence, biological risks and testing decisions.
EO and Gamma Sterilization: Validation, Product Adoption and Load Release
Sterilization validation establishes evidence for a defined process and product scope. Product adoption assesses whether a new device can fit an existing qualified process. Routine load preparation and release apply the established controls to actual production. Keep these questions distinct while linking their records.
Ethylene Oxide EO Sterilization Validation Procedure | ISO 13485 | FDA QMSR
Use EO validation documentation for the defined ethylene-oxide process and associated validation and routine controls.
Gamma Irradiation Sterilization Validation Procedure | ISO 13485 | FDA QMSR
Use gamma validation documentation for dose establishment, mapping and ongoing radiation-process evidence.
Ethylene Oxide Product Adoption Protocol
Use EO product adoption to assess a candidate product against an existing qualified process.
Sterile Load Preparation - Release Procedure | ISO 13485 | FDA QMSR
Use sterile-load preparation and release controls for actual load identity, processing review and authorization.
Medical Device Sterilization Procedure Bundle
Compare the sterilization bundle for coordinated EO, gamma, load-release and environmental-control procedures.
Medical Device Labeling, UDI and CE Marking: Keep Claims Aligned
Labels and instructions communicate device identity, intended use and important information to users. UDI and registration records support identification, while CE marking involves a broader conformity-assessment framework. These activities intersect, but label approval alone does not establish that all market-access obligations have been met.
ISO 13485 Label Review and Approval Procedure
Use label review and approval for label levels, IFU checks, approvals and controlled changes.
Unique Device Identification Procedure
Use UDI documentation for identifier assignment, labeling and associated database records.
Use CE-marking documentation to organize classification, technical evidence and conformity-assessment activities.
Medical Device Labeling Procedure Bundle
Compare the labeling bundle for connected label, UDI, shelf-life and CE-marking procedures.
Internal Audits vs External Medical Device Facility Inspections
Internal audits assess the organization’s quality-system processes against defined criteria. External facility inspections involve a regulator, notified body or other outside party and require a controlled response process. Preparing for both means making evidence retrievable and keeping findings connected to effective action.
Internal Audit Procedure | ISO 13485 | FDA QMSR
Use internal-audit documentation for auditor independence, scheduling, criteria, evidence, findings and follow-up.
Use facility-inspection documentation for preparation and coordination of FDA, notified-body and other external inspections.
Manufacturing Safety Procedures: Hazardous Energy, Biohazards and Respirators
Manufacturing safety documentation should reflect the hazards and work actually present at the facility. Hazardous-energy control, handling potentially contaminated products and respiratory protection each need a defined scope and competent implementation. A generic procedure becomes useful only when it fits the equipment, exposure and personnel involved.
Use lockout-tagout documentation for hazardous-energy isolation, verification and return-to-operation controls.
Use biohazard and waste-disposal documentation for potentially contaminated returns and occupational-exposure controls.
Respiratory Protection Procedure
Use respiratory-protection documentation for the assessed respirator program, including selection and ongoing use controls.
Medical Device Technology Transfer Between Manufacturing Facilities
Moving a medical device, equipment or manufacturing process to another facility is a coordinated change. The receiving site needs more than copied work instructions: it needs the capability, materials, trained personnel and evidence to perform the transferred work. Plan the transfer around those interfaces and the release decisions they support.
Use the technology-transfer procedure to organize the phased transfer of products, equipment and manufacturing processes between facilities.
Need a complete quality-system foundation?
Compare the QMS packages by your organization’s activities. A standalone manual or a focused design collection serves a different purpose from a complete system.
Use the recommendations to compare scope, then adapt and approve the selected documents for your organization. Selecting or purchasing documentation does not establish compliance or certification.
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