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$55.00 Included in your Procedure are sections for: Included in this bundle you will receive six customizable templates: Purchase your simple ready-to-edit BUNDLE and align to clause 7.4 of ISO 13485 today!

$35.00 Included in your Forms Package are six customizable templates: Purchase your customizable forms for your Purchasing and Control of Suppliers process today!

$25.00 Included in your Procedure are sections for: Purchase your simple ready-to-edit template of a Procedure for Purchasing and the Control of Suppliers today!

The simple, easy to edit Post Market Clinical Follow-Up Report template is officially available! Buy it now! $65.00 Included in your Post Market Clinical Follow-Up Report template are prompts for: Purchase your simple easy to edit template of a POST MARKET CLINICAL FOLLOW REPORT UP TODAY!

The detailed Biological Evaluation Plan template as per ISO 10993 is officially available! Buy it now! This template is recommended for class II devices and higher $95.00 This plan is written for manufacturers with high-risk devices that require more detail in their Biological Evaluation Plans. The plan includes: Purchase your Detailed Biological Evaluation Plan today!

ISO 13485:2016 – Quality management systems — Requirements for regulatory purposes Clause 4.2.2: Quality Manual Templates Clause 5.6: Management Review Templates Clause 6.2: Human Resources Templates Clause 7.4: Purchasing Templates

The simple, easy to edit Post Market Clinical Follow-Up template is officially available! Buy it now! $65.00 Included in your Post Market Clinical Follow-Up template are prompts for: Purchase your simple easy to edit template of a POST MARKET CLINICAL FOLLOW UP TODAY!

The simple, easy to edit Quality Agreement is officially available! Buy it now! $75.00 Included in your Quality Agreement are requirements for: Managing changes to product / service specifications Handling non-conformances and dispositioning of non-conforming material Responsibilities when implementing corrective and prevention actions Requirements for change control Requirements when deviating from processes Operational requirements Record… Continue reading QUALITY AGREEMENT BETWEEN MANUFACTURERS AND SUPPLIERS

The simple, easy to edit Biological Evaluation Plan template as per ISO 10993 is officially available! Buy it now! $45.00 This plan is written for new manufacturers with low-risk devices that are looking for a simple-to-populate template. The plan includes: For higher risk devices, we suggest purchasing our more detailed Biological Evaluation Plan for high-risk… Continue reading SIMPLFIED BIOLOGICAL EVALUATION PLAN TEMPLATE

The Essential Requirements (ER) checklist under MDD 93/42/EC is available for purchase $65.00