Expertise.
CE marking of medical
products.
Take advantage of our expertise for smooth approval and complete documentation of your medical devices.
Secure?
Do your products meet all MDR requirements to ensure patient safety?
Compliant?
Are your technical documentation and risk assessments complete for CE marking?
Fit for the future?
Do you always align your product strategy with the latest regulations and standards?
Secure your market access in the EU with our CE expertise.
CE marking of medical devices - regulatory compliance & market access.
CE marking is a key step for the market approval of medical devices in the European Union.
Companies in the fields of medical technology and in-vitro diagnostics (IVD) face the challenge of meeting the extensive MDR requirements. We support you with the conformity assessment, the preparation of your technical documentation and all MDR-relevant processes so that you can enter the European market safely and efficiently.
Our services include testing your products for compliance with the MDR, creating and maintaining technical documentation, carrying out clinical evaluations and developing risk management strategies. We also guide you through the entire certification process and support you with post-market surveillance and vigilance.
CE marking of medical devices - Efficient market approval.
Our solutions support you in the standard-compliant implementation of all MDR requirements in order to introduce your products to the European market safely and in compliance with the law:
Conformity assessment and documentation.
- Determination of all relevant MDR requirements for your product
- Complete creation and updating of technical documentation
- Verification of compliance with the basic safety and performance requirements
Clinical evaluation and risk management.
- Systematic analysis, identification and assessment of product-related risks
- Planning and conducting clinical evaluations to demonstrate efficacy and safety
- Derivation of suitable measures for risk minimization in accordance with MDR
Post-market surveillance and vigilance.
- Continuous monitoring of your medical devices after they have been placed on the market
- Documentation and evaluation of incidents, preparation of relevant reports
- Compliance with vigilance and reporting obligations in the European market
Successful CE marking of medical devices.
FDA approval is a key step for market access in the USA. The following case studies show how our targeted support has helped companies to obtain approval efficiently and with legal certainty.
Introduction of an implant system
CE approval of a diagnostic system
Software as a medical device
Challenge.
Dealing with special MDR requirements for software with regard to validation and data security.
Measures.
- Development of comprehensive technical documentation.
- Risk-based test procedures for validating the software.
- Implementation of a software life cycle process.
Effort.
- Compliance with patient safety and data protection requirements in accordance with MDR.
- Legally compliant and comprehensive documentation for CE marking.
Success.
Approval of the software as an independent medical device.
Secure a legally compliant CE marking.
Our service portfolio for the CE marking of medical devices.
CE marking is essential for the distribution of medical devices on the European market. Our comprehensive range of services supports you in meeting all the requirements of the Medical Device Regulation (MDR) (EU) 2017/745
We support you in selecting the appropriate conformity assessment procedure and prepare the complete technical documentation in accordance with Annex II of the MDR. This includes a detailed description of the product, its design, manufacture and performance data.
Our experts carry out clinical evaluations in accordance with Article 61 of the MDR to demonstrate the safety and performance of your product. We also implement a risk management system in accordance with ISO 14971 to systematically identify and minimize potential risks.
Our experts carry out clinical evaluations in accordance with Article 61 of the MDR to demonstrate the safety and performance of your product. We also implement a risk management system in accordance with ISO 14971 to systematically identify and minimize potential risks.
We support the implementation and certification of a quality management system in accordance with ISO 13485 that meets the requirements of the MDR and ensures the quality of your processes and products.
After market launch, we support you in the implementation of post-market surveillance (PMS) activities, including the creation of PMS plans and reports. We also ensure compliance with vigilance and reporting obligations in accordance with Article 83 of the MDR to ensure the continued safety and performance of your medical devices.
We advise you on the appointment and training of the responsible person for regulatory compliance required under Article 15 of the MDR to ensure that your company complies with the legal requirements.
Shorten your path to successful CE marking.
Related topics - Secure market access with CE marking.
CE marking requires extensive knowledge in various areas. The following topics provide further information and supplementary services:
