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Medical device industry news and trends - and the resources to understand and act on them.


Vital To-Do for 2017: Prepare for ISO 13485:2016

[fa icon="clock-o"] 11/7/16 10:41 AM [fa icon="user"] Stephen Biernacki [fa icon="folder-open'] QMS, iso 13485


“Procrastination is the bad habit of putting of until the day after tomorrow what should have been done the day before yesterday.” - Napolean Hill

It's really never too early, especially when it comes to renewing the certifications you need to keep your product on the market. In fact, the time is now to start your transition to ISO 13485:2016. Certification bodies will have difficulty having enough auditors and long wait times are expected. Don’t get caught in that last minute rush to renew certifications.

R&Q’s QMS expert, Mark Swanson, was a member of the ISO working group that revised ISO 13485, so R&Q can bring you detailed information on the intent behind the requirements. R&Q on the whole will ensure you can fully prepare for your certification audit with minimal issues, keeping your product on markets worldwide.

7-Step Gap Analysis Checklist

R&Q has developed a 7-Step Gap Analysis Checklist, and comes with the expertise to help you smoothly make this transition in an efficient and cost-effective way. Our step-by-step QMS process:

  1. Conduct a gap analysis of your QMS
  2. Create a custom plan to close those gaps
  3. Supplement your staff to update your procedures
  4. Provide training to your staff and top management
  5. Complete your internal audit to verify readiness
  6. Provide a report to management to review readiness
    for your certification audit
  7. Avoid the wait and help arrange for your certification with your certification body (industry is expecting long wait times for audits in 2018)

Based on experience, we highly recommend starting the process today. 

Want additional detail or have questions? Begin a conversation with us. 


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NOTE: In addition to the above, as regulators get closer to the implementation of the Medical Device Single Audit Program (MDSAP) in the next year, R&Q will ensure you have the knowledge to understand this new audit process and will help you lead the discussion with your auditing body.

If you have questions about this definitely let us know.

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