• Expertise You Can Rely On •
Regulatory affairs cover all aspects related to the approval of products in a specific country or region.
The path to successful market approval of medical devices is complex – we make it more transparent and manageable for you. Whether gap analysis, PRRC services, or technical files: with our comprehensive regulatory affairs portfolio, we reliably support manufacturers in meeting regulatory requirements both nationally and internationally.
Benefit from tailored service packages – from simple compliance checks to full-service PRRC. For manufacturers with incomplete documentation, we offer targeted “Regulatory Rescue” packages to quickly get back on track to compliance.
We also help you obtain product approvals worldwide in cooperation with local agents
Contact Us to Schedule an Appointment or Receive Expert Advice:
📞 +49(0) 170-260-52-47
RA Made Simple – With CJ Management Service
PRRC Compact
External PRRC for SMEs
For micro and small enterprises with fewer than 50 employees or less than €10 million in annual revenue – MDR-compliant and professional.
„Regulatory Rescue“
Emergency Support in Case of Failures
For manufacturers with incomplete compliance or for start-ups.
Regulatory Affairs & Compliance
Establishment of Regulatory Processes
Regulatory Intelligence
Laufende Überwachung und Frühwarnsystem auf internationaler Ebene
RA-as-a-Service
Build Your Package From the Listed Services –
or
Tell Us Your Specific Needs
Approval Strategy & Market Access
Consulting for International Markets
Product Approvals
We Support You Nationally and Internationally Until Approval
Technical Files
We Create or Complete Your Technical Files in Accordance With MDR
Offerings | Description | |
• „Regulatory Rescue“ | -Review of existing documentation | |
• Regulatory Affairs & Compliance | Establishment of regulatory processes | |
• Regulatory Intelligence | Ongoing monitoring of standards & regulatory changes (MDR, FDA, ISO, etc.), including an early warning system for clients | |
• PRRC Compact | External PRRC function for EU companies without in-house expertise. Includes compliance checks and audit preparation. Designed for micro and small enterprises with fewer than 50 employees or less than €10 million in annual revenue. | |
• RA-as-a-Service | Flexible assembly of desired services in line with | |
• Approval Strategy & Market Access | Consulting for international markets (USA, Canada, UK, Switzerland, Brazil, etc.), including preparation of technical files and cooperation with local agents. | |
• Product Approvals | -CE marking | |
• TechDok | -For products where clinical data may be waived under MDR Article 61(10) | |