Providing Authorized Representative services for Medical Device manufacturers based outside Europe
For medical device manufacturing companies outside of Europe looking to supply products to Europe, they require an authorised representative.
High Edge Consulting offer the following services:
- Compliance with Article 14 of the Medical devices Directive 93/42/EEC
- Compliance with Article 14 amended by the In Vitro Diagnostics Directive 98/79/EC
- Point of contact for incident reporting
- Product recall procedures
- Complaint handling facilities
- Post Market Feedback resource
- Liaison with MHRA and Notified Body
Call us on +44 (0) 115 921 6200 for a quotation.
