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
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Class I Medical Devices
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Class II & 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
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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
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Medical Device Software (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
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MDD to MDR Transition
Guaranteed conversion to full MDR approval for all forms of legacy medical device.
- All Classes of in vitro diagnostic device
- Dedicated solution for ex-self cert & new IVDs
- Regulation 2024/1860 timeline alignment
- Full IVDR technical files, PERs & more
- Guaranteed IVDR approval