MDR compliance - your path to safe and sustainable market authorisation
The EU’s Medical Device Directive (MDD) is a major challenge for manufacturers: It requires comprehensive evidence of the safety, performance and quality of medical devices.
To help you fully comply with MDR requirements, our solutions are tailored to your business and support you at every stage: from design to implementation:
- Regulatory consulting: Detailed analysis of MDR requirements and development of customised implementation strategies.
- Quality Management: Establish and optimise a robust quality management system that integrates all relevant MDR requirements.
- Clinical evaluation: Helping you produce robust clinical evaluations and evidence on the safety and performance of your products.
- Post-market surveillance: Implementation of sustainable monitoring systems to ensure continued safety and compliance.
With years of experience in the medical device industry, we can help you ensure MDR compliance – for a smooth, internationally recognised market entry and sustainable business success.
MDR compliance - your path to safe and sustainable market authorisation
The EU’s Medical Device Directive (MDD) is a major challenge for manufacturers: It requires comprehensive evidence of the safety, performance and quality of medical devices.
To help you fully comply with MDR requirements, our solutions are tailored to your business and support you at every stage: from design to implementation:
- Regulatory consulting: Detailed analysis of MDR requirements and development of customised implementation strategies.
- Quality Management: Establish and optimise a robust quality management system that integrates all relevant MDR requirements.
- Clinical evaluation: Helping you produce robust clinical evaluations and evidence on the safety and performance of your products.
- Post-market surveillance: Implementation of sustainable monitoring systems to ensure continued safety and compliance.
With years of experience in the medical device industry, we can help you ensure MDR compliance – for a smooth, internationally recognised market entry and sustainable business success.
IVDR Compliance - Your roadmap to safe and sustainable in-vitro diagnostics
The new In Vitro Diagnostics Regulation (IVDR) presents significant challenges for manufacturers: In addition to adapting technical documentation, sound risk analyses, performance evaluations and a robust quality management system are essential.MDR compliance – your path to safe and sustainable market authorisation
Many questions are new and unfamiliar. Our experienced experts will guide you from initial analysis to final market approval:
- Regulatory consulting: Analysis of the requirements of the IVDR and development of individual implementation strategies.
- Documentation & Risk Management: Creation and optimisation of technical documentation and implementation of systematic risk analysis.
- Clinical evaluation: Support in generating and documenting the required clinical evidence.
- Post-market surveillance: Establishing sustainable surveillance systems for continuous assessment of product safety.
With customised solutions and many years of industry experience, we ensure a smooth path through the regulatory challenges – for a future-proof and successful market launch of your in-vitro diagnostics.
IVDR Compliance - Your roadmap to safe and sustainable in-vitro diagnostics
The new In Vitro Diagnostics Regulation (IVDR) presents significant challenges for manufacturers: In addition to adapting technical documentation, sound risk analyses, performance evaluations and a robust quality management system are essential.MDR compliance – your path to safe and sustainable market authorisation
Many questions are new and unfamiliar. Our experienced experts will guide you from initial analysis to final market approval:
- Regulatory consulting: Analysis of the requirements of the IVDR and development of individual implementation strategies.
- Documentation & Risk Management: Creation and optimisation of technical documentation and implementation of systematic risk analysis.
- Clinical evaluation: Support in generating and documenting the required clinical evidence.
- Post-market surveillance: Establishing sustainable surveillance systems for continuous assessment of product safety.
With customised solutions and many years of industry experience, we ensure a smooth path through the regulatory challenges – for a future-proof and successful market launch of your in-vitro diagnostics.