QAEC Limited is an independent UK Consultancy providing Regulatory, Quality and Compliance support to Medical Device and In-Vitro Diagnostic companies of all sizes, from start-up to multi-national companies in multiple markets.
If you have an existing product, an improved product, or a brand new product, QAEC Limited have the knowledge and regulatory experience needed when faced with the challenge of getting product to market and maintaining compliance.
We can help steer you through all areas of Quality Assurance and Regulatory Affairs including EU MDR 2017/745, EU IVDR 2017/746, Audits, QMS, Risk Management, Validation Management and transition, ISO 13485, ISO 9001, CE and UKCA Marking, Technical Files (construction, review, and product registration) and much more.
We can assist at all levels and at all stages in the life of your product.
Contact QAEC Limited to see how we can work together.