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:
- 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.
- 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.
- Internal Standard for Medical Device Quality Management System – ISO 13485: Medical Devices sold and marketed in the European Union
- Stage II – Product Development: Generating the sections of the QMS that pertain to product development:
- Design Controls
- Document Control
- Calibration / Preventative Maintenance of Measurement Equipment
- Labeling and Packaging
- Risk Management
- Supplier Management
- Stage III – Pre-Production: Generating the remaining sections of the QMS not related to production:
- Internal Audits
- Management Review
- Non-Conformances and CAPAs
- Statistical Techniques
- Stage IV – Production: Generating the sections of the QMS pertaining to production
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!