Medical Devices Compliance

Medical Device Academy offers medical devices compliance solution-based consulting services, including:COMPLIANCE SHADOW Medical Devices Compliance

  • Quality Systems audits
  • Compliance remediation
  • Mock FDA inspections
  • ISO 13485 certification
  • Risk management
  • Supplier quality management
  • Management review

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Below are some quotes from Rob Packard, author, from our blog archive

Auditing – “During the audit, you should always make the guide(s) and process owner(s) aware of any potential nonconformities as you find them. This is their opportunity to clarify the objective evidence for you and to explain why there is not a nonconformity.” An Auditor’s Best Practices in Issuing a Major Nonconformity

FDA Inspections – “5. Shut it down – Not running a production line that has problems is a favorite strategy for hiding problems. However, the FDA and auditors will simply be forced to spend more time sampling and reviewing records of the problematic production line.”– 10 Inspection Strategies That DON’T Work

Management Review – “Every Management Review should include an action item scheduling the next Management Review. The timing of the next Management Review should reflect changes planned for the quality system and improvements needed to maintain effectiveness.” – How to Improve Your Medical Device Management Review Procedure

Risk Management – “In order to comply with the EN ISO 14971:2012 version of the risk management standard, you will need to implement risk controls for all risks, regardless of acceptability. However, you will also need to perform a risk/benefit analysis.”   – 7 Deviations within EN ISO 14971: 2012: Risk Evaluation Process

ISO 13485 Certification – “1. Select a certification body and schedule your certification audits (i.e., – Stage 1 and Stage 2). If you want to place devices on the market in the EU, Japan or Canada, make sure your certification body meets the specific regulatory requirements for that market.” 12 Important Tasks for Implementing ISO 13485

Supplier Quality Management – “Finally, my favorite criterion is size. I prefer a supplier that is approximately the same size as my company. If we are the same size, then problems should be equally important for both of us. If my company is bigger, we might tend to bully the supplier and the supplier might have difficulty growing with us. If my company is smaller, our problems might not receive the attention they deserve.” – Supplier Qualification Selection Criteria 

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