Quality Assurance
Beaufort helps develop, implement, and maintain the compliance and quality systems that medical devices and combination product manufacturers must install in order to comply with applicable regulations and standards.
Whether you are taking a new product to market or maintaining the quality of your existing products, Beaufort can help you design straight-forward quality management solutions that are tailor-made to suit the needs and capabilities of your business.
Our quality assurance services for medical device companies include:
- Quality system design and implementation
- Quality system audits and gap analyses to applicable standards: QSR/cGMP, ISO, cGLP
- Pre-certification assessments
- Supplier compliance
- SOP design and implementation
- Document control systems
- Complaint handling system design and implementation
- Corrective and preventative action (CAPA) system design and implementation
- Process and equipment validation: DQ, IQ, OQ, and PQ
- Software and system validation: 21 CFR Part 11
- Quality system training
- Inspection readiness training
- Warning Letter action plans and responses
Review case studies regarding Beaufort’s quality assurance services for medical device manufacturers.
