Meet MDR requirements for your Class I devices while maintaining a lean and targeted approach.
- Full MDR Compliance solution
- Focus on efficiency & alignment
- No unnecessary complexity
- Lifelong Class I device protection
- 100% Guaranteed Conformity
Tailored Consulting Solutions for Medical Devices
Dedicated Solutions with a Focus on Specific Medical Device Types
-
Class I Medical Devices
-
Class IIa & IIb Medical Devices
A dedicated solution for medium-risk devices.
- Comprehensive MDR consulting
- Tailored to device type & clinical field
- Deep subject matter expertise
- Complete transparency
- 100% guarantee of Notified Body approval
-
Class III Medical Devices
Advanced Regulatory Solutions for High-Risk Medical Devices.
- Total MDR compliance solution
- Full Class III technical file development
- In-house clinical expertise
- Up-front pricing
- 100% guaranteed Class III device approvals
-
Software as a Medical Device (SaMD)
Regulatory consulting solutions for the unique needs of Medical Device Software.
- MDR and IVDR compliance for SaMD products
- Dedicated consulting for software devices
- Combined technical, clinical & regulatory expertise
- Tailored SaMD consulting approach
- 100% guarantee of MDR / IVDR approval
-
MDD to MDR Transition for Legacy Devices
Guaranteed conversion to full MDR approval for all forms of legacy medical device.
- Full MDD to MDR compliance solution
- Pre-agreed timelines and completion dates
- Ongoing protection of market access
- Fully guaranteed MDD to MDR transition
- 100% Notified Body approval
Need regulatory support?
Whether you are:
- Preparing for a submission
- Responding to a Notified Body challenge
- Looking for specialist support or a quote
- Unsure about your regulatory strategy
Tell us about your device and what you're facing – one of our clinical or regulatory experts will help you understand the best way forward.