BIOLOGICAL SAFETY

Ensuring Patient Safety with Biological Safety Expertise

All medical devices with direct or indirect contact with patients must be subjected to a biological evaluation. Key2Compliance helps you to plan, perform and document the biological evaluation, with the safety of patients in mind. We have experienced toxicologists with deep knowledge of medical devices and the particular aspects of their evaluation.

We also provide support regarding other aspects of pre-clinical verification/validation activities (Technical Product Management), such as transportation validation, packaging validation, evaluation of shelf life, cleaning validation, bioburden and reprocessing of devices. Contact us today with your specific needs!

We Offer an Integrated Approach to Biological Evaluation and Compliance for Medical Devices

Key2Compliance offers a full suite of services for the biological evaluation and compliance of medical devices, encompassing everything from the development of Biological Evaluation Plans and Reports to specialized training sessions tailored to industry standards.

Biological Evaluation and Risk Assessment

Key2Compliance can help with creating Biological Evaluation Plans (BEP) and Reports (BER), performing GAP-analysis, conducting toxicological risk assessments, and undertaking systematic literature reviews to gather appropriate information.

Compliance and Standards Analysis

Key2Compliance offers GAP-analysis of performed test towards state-of-the-art methodologies to ensure compliance with the latest ISO 10993-series, MDR, and specific global market guidelines, along with developing Standard Operating Procedures for biological evaluation processes.

Testing Coordination

Key2Compliance can help coordinate chemical, in vitro, and in vivo studies with selected test laboratories, oversee simulated use and bench testing of medical devices, and manage the design, planning, and reporting for transportation, packaging, stability, and cleaning validation.

Toxicology Services

Key2Compliance have toxicologists with formal competence (ERT) and experience of evaluating medical devices, chemicals, and cosmetics.

Quality Assurance Support

Key2Compliance can assist with queries related to Good Laboratory Practice (GLP) for quality assurance support.

Training and Education

Key2Compliance conducts tailor-made as well as public training sessions on the biological evaluation of medical devices.
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Want to learn more about the road to CE-mark for your medical device?

The CE mark indicates that a product meets the applicable EU laws and allows the manufacturer to make their device available on the European market. Navigate the complexities of obtaining a CE mark for your medical device with our guide.

In this guide, you will find:

  • Detailed Overview: A comprehensive look at the CE marking process from initial concept to market entry.
  • Regulatory Framework: Insights into the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
  • Quality Management Essentials: Steps to establish and maintain a Quality Management System (QMS) that complies with EU standards.
  • Practical Tips: Expert advice on navigating the certification efficiently to save time and avoid common pitfalls.
 

Download our guide and start your road to CE mark!

Your own biocompatibility expert – on demand!

Many start-up companies and smaller manufacturers do not have the need for a full-time biocompatibility expert. Our team has long experience of biological evaluation of all types of medical devices, from Class I to Class III including combination products, and also experience of ensuring chemical safety and compliance with different regulations including MDR and REACH. We function as the biocompatibility department for many of our smaller clients, with close collaboration over many years.

We constantly keep up-to-date with regulatory requirements and take active part in standardization work through ISO TC 194. This ensures that you get access to top-notch expertise and become aware of upcoming changes to standards before they come into force. Join our client base and get access to our wealth of knowledge as you need it when you need it!

Biocompatibility expert

In vitro methods to replace animal testing

Key2Compliance has long been committed to advancing initiatives that replace animal testing methods for regulatory purposes. Our teams’ experiences have provided us with in-depth knowledge of the pros and cons of different test methods, positioning us well to advise clients who wish to use alternatives to animal testing as much as possible.

Collectively, we strive to make the biological evaluation process more cost-effective for our clients by combining tests and finding the right balance for what is required. Our extensive hands-on experience with in vitro and in vivo techniques in the lab makes it easier for us to assist in test design and to review plans and reports, ensuring that tests are both performed and documented in a way that is optimal for our clients.

In-depth knowledge of Good Laboratory Practice and ISO 17025

All biological tests performed to evaluate the safety of medical devices must follow strict quality assurance requirements, for the data to be trusted by authorities and accepted under other jurisdictions than where the test was performed. 

The team has extensive experience of quality assured laboratory work, both GLP, ISO 17025 and ISO 15789. Kristina Fant, the Director of Biological Safety, is also a co-author of the OECD guidance document GIVIMP (Good In Vitro Method Practices). She regularly gives courses in Good Laboratory Practice and is a Technical Assessor for the Swedish national GLP compliance monitoring authority Swedac during GLP inspections.

The team can assist in laboratory selection, in all aspects of study design, can verify that all requirements on test item identification are being met, and can assist in reviewing test reports to ensure that the procedures and test items are described in sufficient detail and in accordance with all requirements in the quality management system.

Rely on our experts

“To perform a biological evaluation is very much a team effort, where in-depth knowledge from many different fields is required – toxicology, materials science, manufacturing, clinical use of the device, laboratory evaluation, and much more. We always want to make working together a learning experience for all partners involved, and we are happy to share what we know with our clients as it only benefits the industry and in the end the patients if the general competence on biocompatibility increases.”

Kristina Fant, Director of Biological Safety

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