Clinical Evaluation Procedure Bundle
SKU:
CEBNDL
$499.00
$499.00
per item
The Clinical Evaluation Procedure Bundle includes procedures for Clinical Evaluation, Clinical Investigation, Post Market Surveillance and PMCF, and CE Marking requirements.
- MDR EU 2017/745 Compliant
- ISO 14155:2011 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MEDDEV 2.12.2
- MEDDEV 2.7.1, Rev 4
- MS Word Format
- Instant Download Digital Content
Clinical Evaluation Procedure BundleThe Clinical Evaluation Procedure Bundle includes four (4) Standard Operating Procedures relating to Clinical Evaluations, Investigations, Surveillance and CE Marking.
Clinical Evaluation Procedure Bundle ContentsThe Clinical Evaluation Procedure Bundle includes the following procedures:
Clinical Evaluation ProcedureThe Clinical Evaluation Procedure provides detailed instruction on:
Clinical Investigation ProcedureThe Clinical Investigation Procedure provides detailed instruction for clinical investigation planning, development and content of a clinical investigation plan (CIP), sponsor obligations, and detailed instruction on how to generate a clinical investigation report per ISO 14155:2011.
Post Market Surveillance ProcedureThe Post Market Surveillance Procedure governs all post market surveillance activities and provides instruction on: Post Market Surveillance Plan and Report (Includes Sample Plan); Post Market Clinical Follow-Up (PMCF) requirements; and Periodic Safety Update Reports (PSUR) content for Class IIa, IIb and Class III devices.
CE Marking ProcedureThe CE Marking Procedure provides a method to assure that all CE Marked medical devices commercialized in the Union are in compliance with the European Medical Device Regulation MDR (EU) 2017/745.
Clinical Evaluation Procedure Bundle ComplianceThe Clinical Evaluation Procedure Bundle is MEDDEV 2.7.1 Rev 4, MEDDEV 2.12.1, ISO 14155:2011, MDR 2017/745, FDA QSR and ISO 13485:2016 compliant.
For more information about our Clinical Evaluation Procedure Bundle contact us at info@aplyon.com
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Clinical Evaluation Bundle Contents
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Clinical Evaluation Procedure
$199.00
The Clinical Evaluation Procedure governs the entire clinical evaluation process from scope definition through Clinical Evaluation Report (CER). The MEDDEV 2.7/1 Rev 4 compliant Clinical Evaluation Procedure also governs Post Market Clinical Follow-up (PMCF).
- MEDDEV 2.7/1 Rev 4 Compliant
- MDDEV 2.12/2 Compliant
- MDR (EU) 2017/745 Compliant
- ISO 13485:2016 Compliant
- MS Word Format
- Instant Download Digital Content
Post Market Surveillance Procedure
$149.00
The Post Market Surveillance Procedure governs all post market surveillance activities and provides instruction on: Post Market Surveillance Plans and Reports (Includes Sample Plan); and Post Market Clinical Follow-Up (PMCF) requirements.
- MEDDEV 2.12/1 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- MS Word Format
- Instant Download Digital Content
CE Marking Procedure
$149.00
The CE Marking procedure governs the content of CE Technical Files and Design Dossier's. The CE Marking Procedure also provides instruction on device classification in accordance with Medical Device Regulation MDR (EU) 2017/745.
- MDR EU 2017/745 Compliant
- ISO 13485:2016 Compliant
- MEDDEV 2.4.1 Compliant
- MS Word Format
- Instant Download Digital Content
Periodic Safety Update Report (PSUR) Procedure
$149.00
The Periodic Safety Update Report (PSUR) Procedure provides detailed guidance on the required content of a Periodic Safety Update Report (PSUR) made part of the company’s post market surveillance and vigilance system.
- ISO 13485:2016 Complaint
- MDR (EU) 2017/745 Compliant
- MS Word Format
- Digital Content - Instant Download