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.
IVDR Readiness - Efficient compliance with IVDR requirements.
Our IVDR Consulting Services offer you comprehensive support in complying with IVDR requirements and obtaining market authorization for your in-vitro diagnostic products.
The IVDR (In-vitro Diagnostic Regulation) places new requirements on diagnostic products, and our experts support you in meeting these efficiently and safely. We develop tailor-made strategies to meet the IVDR requirements, identify compliance gaps and optimize your processes. We support you throughout the entire approval process, from preparing documentation to communicating with the notified bodies.
Our services include:
- Regulatory compliance: Integration of IVDR requirements into your processes and support in complying with all regulatory requirements.
- Technical documentation and approval process: Preparation, review and submission of technical documentation and risk management.
- Post-market surveillance and vigilance: development of post-market surveillance plans and incident reporting in accordance with IVDR requirements.
IVDR Readiness Services at a glance.
Our IVDR Consulting Services provide you with comprehensive support in complying with the IVDR and obtaining market authorization for your diagnostic products.
Regulatory compliance.
- Analysis of existing processes for IVDR conformity
- Measures to eliminate compliance gaps
- Support in complying with all regulatory requirements
Technical documentation.
- Preparation of technical documentation in accordance with IVDR requirements
- Risk management and performance evaluation according to IVDR standards
- Submission of the documents to the notified bodies
Post-market surveillance.
- Development of post-market surveillance plans
- Reporting incidents to the competent authorities
- Vigilance measures to ensure product safety
Successful IVDR readiness projects.
Our IVDR consulting projects support companies in efficiently meeting the new IVDR requirements and bringing their products safely to market.
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 the IVDR compliance of your products.
Our IVDR Readiness Service Portfolio.
Our IVDR Readiness Service portfolio offers comprehensive solutions to ensure IVDR compliance and market authorization for your diagnostic products.
We support you in integrating the IVDR requirements into your processes and meeting all regulatory requirements. Our service includes the complete preparation of documentation and the submission of technical documentation to the notified bodies.
- Risk management system (ISO 14971): We implement a comprehensive risk management system that covers the entire product life cycle and is compliant with the requirements of the IVDR (Article 10) and ISO 14971(
- General Safety and Performance Requirements (GSPRs): We ensure that the essential safety and performance requirements of your products are met in accordance with Annex I of the IVDR
We prepare the technical documentation, carry out risk assessments and ensure successful submission and communication with the notified bodies.
- Technical documentation (Annex II): We create and maintain all necessary technical documents, including device description, risk assessment, verification and validation
- UDI and EUDAMED registration: We support you with the implementation of the UDI and registration in the EUDAMED database to ensure the traceability of your products
Our experts develop post-market surveillance plans and carry out vigilance measures to ensure the safety of your products even after market approval.
- Post-market surveillance (Annex III): We provide continuous monitoring of your products to verify and ensure their performance and safety after market launch
- Vigilance and reporting: Regular reporting of safety-related data to the competent authorities in accordance with IVDR requirements (Articles 82 & 83)
