We can support in registration of medical devices in Europe
(CE certification) and other markets worldwide, such as US, Australia and Canada for both Medical devices and IVDs.
Example of areas where we offer regulatory support:
Establish and maintain your CE certification and technical file/design dossier
Product modification strategies and management
Agency/Notified Body interactions
Prepare for CE certification according to MDR respective IVDR
We provide quality expertise throughout the whole life cycle. We can help you establish and maintain your quality system in accordance with ISO 13485 and US 21 CFR 820.
Examples of areas where we offer support:
- Building quality systems
- Audit preparation
- Implementation of the MDSAP program, training and gap analysis
- Internal and supplier audits
Revised European legislation (MDR/IVDR)
The new European regulation for medical devices is coming into effect in May 2020 (MDR) respective May 2022 (IVDR). The regulations feature several significant changes and we can help you in your transition to the revised requirements.
Our experts can support in the assessment of your CE technical documentation and processes to identify and manage the steps needed to meet the requirements in the new requirements.
EU Authorised Representative
For companies not located in the European Union an authorised representative must be designated to act on your behalf.
As your authorised representative SRS will act as primary contact for the EU authorities, manage national registrations and notify reportable incidents to the relevant Competent Authorities.