Services
Benefit from our RA QA expertise
Our Services
00 46 730 70 10 44
Regulatory
Our regulatory affairs services offer consultancy on:
- CE Marking.
- Directives MDD/MDR
- IVD/IVDR, AIMD, MD, LVD
- EMC, ROHS, REACH, red ETC.
- Applications/registrations: FDA
- Gap analysis (Product standard)
- Due diligence
- Build technincal file
- Project Manager
- Moderator in workshops for e.g. Risk/Usability standard
- Set up Regulatory strategy
- Regulatory Affairs Manager
- Various support for test house issues
- Participate as RA/QA during development
- Investigations
Quality
Our quality expertise is extensive and covers:
- Participation in development projects
- Gap analysis (process)
- Quality System build
- Quality Assurance Manager
- Issue SOP/process documents
- Investigations
- Participate in audits
- Lead Auditor
- FDA mock-up audit
- Various support for test house issues
Due Diligence
We can participate in due diligience activites prior to a potential acquisition when evaluating a target company or its assets for an acquisition.
We can evaluate the companys' regulatory and/or quality status and provide valuable feedback.
Education
We offer company specific courses which we instruct.
- CE-marking incl. MDR
- IVDR, MDR
- Usability
- Product development
- Risk management
- Software and apps
- 60601- standard series
- 61010-standard series
Standards
Standards and standardization:
- IEC/EN 60601-1
- IEC/EN 60601-1-X
- IEC/EN 60601- 2-X
- UL/CAN/CSA/AAMI for 60601-series etc.
- IEC/EN 61010-1
- IEC/EN 61010-2-101
- IEC/EN 61010-2-081,
- IEC/EN 61010-2-XX
Process standards as:
- IEC/EN 62366-1 (Usability)
- ISO/EN 13485 (Quality system)
- ISO/EN 14971 (Risk management)
- IEC/EN 62304/82304 (Software)
