Procedure Bundles
Choose connected documents without duplicate purchases
Use a bundle when you need several related procedures to support one workflow. Compare its listed contents with the documents you already own and the activities you need to implement.
A procedure bundle covers its named workflow; it should not be assumed to provide a complete standalone QMS. For example, clinical evaluation, PMCF and PMS documents have connected roles, but each addresses a different activity or record.
Open each bundle's product page for the exact included products, previews and value statement. Follow the links to individual procedures when you need only one component. Check for overlap before adding both a bundle and an included product to your order.
Practical guides
Use these guides to understand how related procedures work together, then compare each bundle’s actual content list.
Medical Device Design Controls: Requirements, Reviews and Transfer
Medical Device Risk Management: Design and Process Risks
Medical Device Software: Development, Validation and Clinical Evidence
Clinical Evaluation Reports: Turning Medical Device Evidence into Conclusions
Medical Device Process Validation: Protocols, Statistics and Mold Processes
Choose a bundle when the connected workflows are missing together
A coordinated document set is useful when several related controls need to be established together. Define the missing workflows first, then compare the bundle’s exact contents with existing procedures. A larger collection is not automatically the better purchase.
Your decision | Starting point | What to check |
Design development gates and evidence | Four-procedure Design Control Bundle | Control, Review, Transfer and Verification/Validation. |
Lifecycle and focused risk analyses | Four-procedure Risk Management Bundle | Risk Management, Design Risk, Process Risk and Design Analysis. |
Validation planning and study-document structure | Four-procedure Process Validation Bundle | Process Validation, Protocols/Reports, IQ and Statistical Techniques. |
Software lifecycle and supporting evidence | Five-document Software Bundle | Separate device development, production/QMS assurance, usability and clinical evidence. |
Clinical and continuing evidence workflows | Five-product Clinical Evaluation Bundle | Check included investigation documents and separately listed PSUR. |
What to address first
Compare the standalone procedure, bundle and broader collection using the linked comparison guides. Check existing ownership and exclusions before selecting the set. If the missing work is actual testing or investigation, a wider document purchase may not address it.
Individual document, bundle or existing system?
Bundles supply editable documentation within their listed scope. They do not supply a completed risk file, executed qualification, clinical data or certification. Injection Mold Validation is separately sold from the process-validation bundle, and the 26-procedure design collection is not a standalone QMS.
Relevant document options
Design Control Procedure Bundle | ISO 13485 | FDA QMSR
Risk Management Procedures Bundle | ISO 13485 | FDA QMSR
ISO 13485 Process Validation Procedure Bundle
Medical Device Software Procedure Bundle
Clinical Evaluation Procedure Bundle
Browse all documentation guides by topic
Use the medical device document selector