Expertise.
IVDR Readiness.
Ensuring IVDR compliance for in-vitro diagnostics products and accelerated market approval through targeted advice.
Compliant?
Do your products meet the new IVDR requirements and are they ready for market authorization?
Reliable?
Are your processes and documentation IVDR-compliant and audit-ready?
Efficient?
Are your IVDR processes optimized to save time and costs?
Ensure your IVDR compliance and market authorization.
Efficient compliance with IVDR requirements.
Our IVDR Consulting Services offer you comprehensive support in complying with IVDR requirements and obtaining safe market authorization for your diagnostic products.
The IVDR (In-vitro Diagnostic Regulation) places new and extensive requirements on diagnostic products. Our experts identify compliance gaps, optimize your processes and develop strategies that are both efficient and sustainable. We guide you through the entire approval process, from preparing documentation to communicating with notified bodies.
Our services include:
- Regulatory compliance: Support with the full integration of IVDR requirements into your processes.
- Technical documentation and approval process: preparation and submission of technical documentation, risk management and preparation for audits.
- Post-market surveillance and vigilance: development and implementation of post-market surveillance plans, reporting and vigilance measures.
IVDR Readiness Services at a glance.
Our IVDR Consulting Services cover all important areas to bring your products safely and IVDR-compliant to the market.
Regulatory compliance.
- Review and analysis of your existing processes for IVDR compliance.
- Measures to eliminate compliance gaps.
- Implementation of the general safety and performance requirements according to Annex I of the IVDR.
Technical documentation and approval.
- Preparation of technical documentation in accordance with Annex II of the IVDR.
- Support with UDI implementation and registration in the EUDAMED database.
- Preparation and submission to the Notified Bodies.
Post-market surveillance and vigilance.
- Development and implementation of post-market surveillance plans.
- Assistance in reporting incidents to authorities in accordance with Articles 82 and 83 of the IVDR.
- Continuous monitoring of product safety for long-term compliance with the IVDR
Successful IVDR readiness projects.
Our IVDR consulting projects support companies in the successful implementation of IVDR requirements, from GAP analysis to market authorization.
IVDR readiness for a leading diagnostics manufacturer
IVDR compliance and market adaptation for a medical technology company
IVDR risk management for a medium-sized diagnostics company
Challenge.
A medium-sized diagnostics company had to provide the new IVDR risk assessments and clinical evidence for a large number of products.
Measures.
- Prioritization of products to meet the IVDR requirements
- Preparation of clinical evidence and technical documentation
- Development of a long-term IVDR compliance strategy
Results.
- 20% lower costs for IVDR implementation
- 40% reduction in potential risks
- Long-term compliance with IVDR requirements
Success.
The company was able to implement the IVDR requirements efficiently and cost-effectively.
Ensure your IVDR readiness.
Our IVDR Readiness Service Portfolio.
Our IVDR Consulting Service portfolio offers comprehensive solutions to ensure IVDR compliance and market authorization for your diagnostic products.
We analyze your existing processes and identify compliance gaps in order to seamlessly integrate the IVDR requirements. Our experts support you in the implementation of the General Safety and Performance Requirements (GSPR) and the creation of clinical performance evaluations. In this way, we ensure that your products meet all regulatory requirements. You can find out more in the IVDR guidelines of the European Commission.
Our experts create and maintain your technical documentation in accordance with the requirements of the IVDR, including UDI implementation and registration in the EUDAMED database. We also support you in direct communication with notified bodies and optimize the approval process. You can also find more information on technical documentation on our Technical documentation and approval page.
We develop robust systems to continuously monitor your products after market authorization. This includes the creation of post-market surveillance plans, regular generation of Periodic Safety Update Reports (PSURs) and the reporting of safety incidents in accordance with Articles 82 and 83 of the IVDR. Visit our Post-Market Surveillance page for more details.
Our service includes the implementation of comprehensive risk management systems that cover the entire life cycle of your products. We are guided by the requirements of IVDR and ISO 14971. Further information can be found on our Risk Management page or directly in the ISO 14971 guidelines.
We offer tailor-made training courses to familiarize your team with the most important regulatory requirements of the IVDR. In addition, we organize practical workshops to prepare for audits. The European Commission provides further information on training programs.
Ensure the IVDR compliance of your products.
Related topics for your IVDR preparation.
These complementary services support you in meeting the requirements of the IVDR and successfully bringing your in-vitro diagnostics to market:
