To fully meet clients’ need, we offer extensive expertise and capabilities, from the design of a product to its market launch and beyond, through three independent services: consulting, testing, and cleaning/sterilisation/packaging. Our responsibility goes beyond the project as we support the entire process from A to Z.
Consulting
Thanks to our expertise, versatility and regulatory proficiency, Eurofins Medical Device Consulting will find the safest and the fastest strategy to launch your product on the market. Supporting with understanding regulations, passing audits, conducting risk and gap assessments, and more, we provide you with a custom-made service, throughout the entire lifecycle of your product:
- At the design validation stage, we set up a project plan and handle the V&V (Verification & Validation), providing protocols, execution & reports for a successful regulatory submission.
- Technical documentation (preparing and writing of the dossier) and set-up & maintenance of your Quality Management system during pre-submission and post-marketing surveillance.
- We evaluate usability along with risk analysis, as an integral part of risk management, to estimate the risks associated with the use, errors of use and ergonomic characteristics of the device.
- In the pre-clinical phase, we help you to optimize your testing strategy through biocompatibility and absorption evaluation. This encompasses a biological and toxicological risk assessment, biological evaluation plan and report, absorption profile evaluation & chemical characterisation plan.
- Then, we provide a Clinical Evaluation Plan & Report, which summarises the strategy & presents the relevant data from the clinical evaluation results to submit to the authorities.
- Our QA/RA services after regulatory approval encompass:
- Outsourcing the PRRC role
- Vigilance
- Re-certification
- General Safety and Performance Requirements (GSPR)
- Post-Marketing Surveillance (PMS) including Post Market Clinical Follow-up (PMCF) and Periodic Safety Update Reports (PSURs)
- Internal audits
- Computer Software Validation (CSV) under GMP
- Software as Medical Device (SaMD)
- In-Vitro Diagnostics (IVD)
Testing
The Eurofins Medical Device Testing network of laboratories offers comprehensive services to support clients to ensure the safety, efficacy, and high quality of their medical devices.
We provide experienced GMP/GLP/ISO 17025/ASCA testing to ensure rapid turnaround times with the highest level of service. Eurofins Medical Device Testing companies use the most advanced technologies to meet the chemical, microbiological, biocompatibility, mechanical and packaging testing needs of their clients.
Our testing capabilities encompass:
- Chemical and physical characterisation such as extractables & leachables, material & product stability, and ethylene oxide (EO) residuals testing
- Biocompatibility testing – we manage the entire ISO 10993 series in-house
- Tests for combination products such as drug release, sorption studies & syringe testing
- Microbiological testing, sterility, bioburden, endotoxins & microbial identification
- Viral inactivation studies
- Packaging validation
- Sterilisation validation
- Reprocessing validation
Assembly, packaging & sterilisation
As the one-stop-shop for the cleaning, assembly, packaging & sterilisation of your medical device, Eurofins Medical Device combines expertise and agility to provide tailor-made solutions. Every year, several million medical devices are packaged according to applicable standards and regulations, and we carry out no less than 600 validations to guarantee the quality of products & processes. Every project is unique: we partner with our customers to find the right solution, while developing the most innovative technologies.
Our services:
- Packaging : tailor-made solutions are provided to guarantee the best design, functionality and security.
- Cleaning: to create the consistent level of cleanliness required for a reliable sterilisation process, we use effective and innovative processes such as ultrasonic cleaning, vacuum extraction and immersion rinsing bath or cleaning in the cleaning and disinfection machine.
- Assembly and engineering are determined in consultation with the client, by proficient and experienced teams, and respect international regulations.
- Sterilisation is provided by means of gamma rays or ethylene oxide (EO) with our in-house EO sterilisation plant or at external accredited partners.
In addition, our teams offer all associated validations, as well as complete documentation.
Why Eurofins?
We value your success. Our key words are:
- Proficiency: With 30+ years of scientific & regulatory expertise, we conduct 1,700 consulting projects, 23,000 biocompatibility projects, and nearly 600 sterile packaging projects every year.
- Availability: We provide a local point of contact with a single Project Manager, as well as global capacities.
- Flexibility: We adapt to your needs in terms of business model, services, laboratories and ad hoc investments. Dialogue and transparency are key, which we achieve through regular and proactive communication.
- Reliability: We aim to create a long-lasting partnership with our clients and to get their product on the market in the fastest and safest way possible. Our responsibility goes beyond the project as we support the entire process from A to Z.
