Medical Devices
At SRS offers a wide range of regulatory and quality services. Our professional consultants have years of experience and can offer assistance as you need it.
Regulatory
We provide support during development and with registration of medical devices and IVDs in Europe (CE certification) as well as other markets worldwide, such as USA, Australia, China and Canada.
Example of areas where we offer regulatory support:
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Establishment and maintainance of your CE certification and technical file/design dossier
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Product modification strategies and management
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International registrations
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Agency/Notified Body interactions
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Preparations for CE certification according to MDR respective IVDR
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MDR gap-analysis and implementation
Quality Systems
We provide quality expertise throughout the whole product life cycle. We provide support to establish and maintain your quality system in accordance with ISO 13485 and US 21 CFR 820.
Examples of areas where we offer support:
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Building and updating quality systems
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Audit preparation
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Implementation of the MDSAP program, training and gap analysis
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Internal and supplier audits
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MDR gap analysis and implementation
Revised European Legislation (MDR/IVDR)
The new European regulation for medical devices is coming into effect in May 2021 (MDR) respective May 2022 (IVDR). The regulations feature several significant changes and we provide the service tu support in your transition to the revised requirements.
Our experts can support in the assessment of CE technical documentation and processes to identify and manage the steps needed to meet the MDR 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.
Person Responsible for Regulatory Compliance (PRRC)
MDR and IVDR brings with them the requirement for a person responsible for regulatory compliance (PRRC). In other words, ALL legal manufacturers (and authorized representatives) must have a PRRC assigned from 26 May 2021.
This person has to meet minimum qualification and experience requirements.
For “micro” and “small” manufacturers this role can be outsourced, and SRS will be able to support you with the PRRC.
Please feel free to contact me to discuss how we can support you.
Mail: Rye@srs.se
Phone: +46 8 121 326 75