We can offer strategic consulting and tactical solutions to understand and overcome the complicated world of Medical Device Compliance with specialist knowledge of the Medical Device industry including CE marking, product compliance and specific market requirements.
Utilise knowledge and expertise gained from working for large OEM’s in excess of 20 years across the Healthcare & Automotive industries across a range of disciplines. Let us assist your business in meeting those all important objectives, without having to employ extra personnel!
For manufacturers and distributors based outside of the European Union, appointing an Authorised European Representative is an essential step to market in the region. M D C Consultancy Ltd can provide an EU Authorised Representative Service as a gateway to the European market. Utilise expert advice and knowledge from medical device specialists. Let us take care of your registration and CE obligations.
We offer a range of services in Quality, Regulatory, Technical & Compliance within the Medical Device arena and Automotive Industries including New Product Development, Lean Initiatives, Problem Solving, Supply Chain Management, Business Improvement Tools, Quality Tools, Quality Remediation, Internal & External Auditing, CAPA, Product Evaluation, KPI’s, Cost Of Quality, Project and Environmental Management, Due Diligence, Public and Product Liability Claims, CE marking, Product Compliance, Market Applications and Submissions, CFR 820 requirements, Homologation applications, Product recalls, Third Party Testing and EU representation.
Product & System Standards
