TopQualityEngineering | QMS



Developing a Quality Management System (QMS) for Medical Device companies is key to ensure compliance with regulatory requirements.

A QMS should be developed and implemented in phases, consistent with the growth of the company, to ensure compliance through the various stages.

Top Quality Engineering uses the following 4-stage approach to build and help you implement a full quality system:

  1. Stage I – Identifying the Regulatory Strategy: Based on classification of the Medical Device and markets to which the Medical Device will be sold and marketed in, identifies the compliance requirements in developing a QMS.
    1. FDA’s Quality System Regulation (QSR) – 21 CFR Part 820: Medical Devices sold and marketed in the United States. Classification of the device identify the requirements that are applicable.
    2. Internal Standard for Medical Device Quality Management System – ISO 13485: Medical Devices sold and marketed in the European Union
  2. Stage II – Product Development: Generating the sections of the QMS that pertain to product development:
    1. Design Controls
    2. Document Control
    3. Calibration / Preventative Maintenance of Measurement Equipment
    4. Labeling and Packaging
    5. Risk Management
    6. Supplier Management
    7. Training
  3. Stage III – Pre-Production: Generating the remaining sections of the QMS not related to production:
    1. Internal Audits
    2. Management Review
    3. Non-Conformances and CAPAs
    4. Statistical Techniques
  4. Stage IV – Production: Generating the sections of the QMS pertaining to production
Upon the completion of the 4-stage approach, a complete QMS is in place and ready for regulatory approval.

Top Quality Engineering offers the following services:

  • Develop a personalized ISO13485 / 21CFR820 compliant Quality Management System, based on your company’s strategy and infrastructure
  • Provide ISO13485 / 21CFR820 compliant templates for each of the QMS procedures

Contact us for a copy of an ISO13485:2016 to 21CFR820 table, at no charge!