Medical Device Manufacturing: Quality Cheat sheet

Over the years LSO has worked with numerous start-ups – visionaries with innovative products and good business sense, but lacking knowledge on the intense amount of regulatory policies and procedures involved in manufacturing and getting a med device to market.  We have guided many of our clients through the process of 510K approvals, clinical trials and developing a FDA approved quality system.  What we noticed was that people face an initial road block with the colossal number of abbreviations that are used in nearly every aspect of the industry.

So we compiled a list of the most important abbreviations that you need to know to get more comfortable with the industry jargon. Think of it as your very own ‘Medical Device Quality Cheat Sheet’:

Quality System & Documentation:

  1. 510(k) – Application submitted to the US FDA
  2. PMA – Pre-Market Approval. Required by the FDA for high risk devices to guarantee safety and effectiveness.
  3. CE Mark/CE Marking – The official “passport stamp” that tells European Competent Authorities your product has met the appropriate Directives
  4. Class 1 device – Low risk medical devices
  5. Class 2a/2b medical device – Includes a wide range of medium risk medical devices.
  6. Class 3/4 medical device – High risk devices. Class 4 is used assigned in Canada only
  7. ISO 13485 – International quality management standard for the medical device sector
  8. FMEA – Failure Mode and Effects Analysis
  9. QC – Quality Control
  10. QSP – Quality System Procedure
  11. QSR – Quality System Regulations
  12. cGMP – Current Good Manufacturing Practices. Also known as GMP
  13. cGMPR – Current Good Manufacturing Practice Regulations
  14. DHR – Device History Record
  15. DMR – Device Master Record
  16. NCR – Non-Conformance Report
  17. CAPA – Corrective and Preventive Action
  18. CC – Customer Complaint

Organizations & Regulatory Bodies:

  1. ANSI – American National Standards Institute
  2. CDC – Centers for Disease Control & Prevention (USA)
  3. EN – European Standard
  4. FDA – Food and Drug Administration
  5. ISO – International Standards Organization
  6. OSHA – Occupational Safety and Health Administration (USA)

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