From left: Winta Woldai, Emma Pedersen, Kristina Fant
Patient safety is crucial, and a part of ensuring that is to make certain that the right materials are used in medical devices. As a full-service partner, Key2Compliance is assisting companies in the life science area with everything from risk management and compliance, to training and guidance in how to meet the regulatory requirements. When it comes to the biological evaluation of medical devices, our Biological Safety team can provide guidance and support regarding the planning, performance and documentation of the biological evaluation. The team can also support in the selection and planning of biological tests throughout the production process to ensure that the final product is compliant. The Key2Compliance’s Biological Safety team – one of the most experienced teams there is in this area.
The Biological Safety team at Key2Compliance has a wide range of skills regarding biological safety evaluations of medical devices. The core focus for the team is writing Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER). The team also provide services regarding toxicological risk assessments of chemicals, processing agents and device materials, examine any toxicological effects of the materials, manage studies, write recommendations/rationals, update documentation regarding materials, help selecting appropriate materials, and provide support regarding other aspects of pre-clinical verification/validation activities and much more.
The director of the team is Emma Pedersen (PhD). By her side she has Kristina Fant (PhD). Together they have extensive experience in biological evaluation of medical devices, including practical work in the laboratory with biological and chemical testing and toxicological risk assessments, as well as GLP, ISO IEC 17025 and the corresponding regulatory frameworks. They are members of the Swedish standardization committee (SIS TK 340) responding to ISO TC194, developing the ISO 10993 series. Both Emma and Kristina have a background at RISE Research Institutes of Sweden, where they in addition to working with biological evaluation of medical devices also pushed initiatives to replace animal testing methods for regulatory purposes, being involved in several international development and validation studies regarding in vitro test methods, e.g. skin irritation of medical devices and test methods for endocrine disruptors. They still have a special interest in the 3Rs (Replace, Reduce, Refine). Emma is for example assisting Kemikalieinspektionen with support related to development and review of new OECD in vitro test guidelines, and Kristina is a delegate of the Swedish National Committee for the Protection of animals used for scientific purposes, which is the steering group for the Swedish 3Rs centre. Both are devoted to improving quality in in vitro testing and research, and are co-authors of the current OECD GIVIMP (Good In Vitro Method Practices) guideline. Kristina is also a Technical assessor for the Swedish national monitoring agency Swedac during GLP inspections.
Completing the team is Winta Woldai, a toxicologist with experience in regulatory toxicology and QA, and with a background as a QA/RA specialist in a pharmacy chain and life science consultant within medical device. Winta has a dual role at Key2Compliance, bringing her expertise across these areas; a QA/RA consultant in the QA medical device team; and a toxicologist in the biological safety team. Winta has experience in writing toxicological safety assessments, cosmetic product safety reports in accordance with Annex 1 to Regulation 1223/2009 as well as MSDS in accordance with REACH article 31, and classification and labelling in accordance with regulation 1272/2008 (CLP). Winta is a registered ERT toxicologist.
According to director Emma, the members of the team complement each other perfectly with expertise in physics, chemistry, biology, toxicology, and QA. “Together we have decades of experience in labwork, testing methods, quality assurance, regulatory framework and so much more. All with a focus on the patient safety. Both with MDR and the more recent standards in the ISO 10993 series, the requirements for biocompatibity and control of the chemical content of a device have increased. Due to our collective experience, our team can assess the client’s needs and help them determine what is the most reasonable and necessary way forward.”
The Biological Safety team is used to help clients in all stages of development, from idea to market, and beyond. “There is no typical client” says Emma, “We’re helping startups that doesn’t even have a product yet, as well as established companies that have had a product for 30 years but now need to show that the product is biologically safe to meet the requirements of MDR.” What is unique for the team is that we have many other competences besides our main area. Although the main focus of the team is the biological evaluation of medical devices, the toxicology knowledge and toxicological testing insights that the group has is equally relevant for other products such as cosmetics, industrial chemicals or pharmaceuticals. Considering our background in replacing animal testing, alternative testing methods are typically developed for chemicals first (due to the EU chemicals legislation REACH and the cosmetics regulation, where there is a ban on using animal tests), which means that we also have a lot of knowledge applicable in those field” says Emma.
The Biological Safety team can assist with everything from being a discussion partner to documenting and coordinating the entire development and evaluation process. The most common challenges for the clients are to choose materials that meet the requirements, or the need to update the testing and documentation to meet new standards and regulations. “Biological evaluations and toxicology require a specialized competence that is difficult, for companies to have. This team has extensive experience of working in labs and can explain to the clients why they need to do tests and why even small details make a difference,” says Emma. She describes the process of guiding the clients as following, “The first thing we do is to assess how the product is used and how it comes in contact with the patient, how often and for how long it is used. Then we ask what kind of material that is in the product and how it is documented. It is not uncommon that the documentation is insufficient, and in that case, we need to request more information from the raw material suppliers. We also need details of the manufacturing and sterilization process. We help the client through this process by writing a biological evaluation plan (BEP), after that we coordinate the lab tests the client need to do, before we sum things up and conclude on the biological safety in a biological evaluation report (BER).”
According to Emma, education is an important part of how they help the clients, “We are happy to share our knowledge with the clients. Many of them don’t have knowledge of what the materials contain, so we train them in what to ask for in contact with their suppliers and what they need to be aware of, in order to meet the regulations. We gladly share this knowledge because it only benefits the industry and the patients if the competence regarding biocompatibility increases. We want to give the clients much more than just the necessary documents.”
This experienced team is always evolving and bringing new insights and services to the biological safety area. As a director, Emma wants to make the process more cost effective for the clients by combining tests and finding the right balance for what’s required, as well as introduce more accurate tests into the field. “Animal testing sometimes has a low accuracy compared to the effect in humans. In vitro tests can be so much better and more predictable, as well as safer for humans. By in vitro testing we can vary one parameter at a time and get more precise results,” says Emma, “This team has extensive knowledge of validating in vitro methods to replace animal testing. Such validation includes extensive work to evaluate the repeatability, reliability and performance of the test method. They also have a long experience from working hands-on with in vitro techniques in the lab, and we have expertise in testing. We always want to help our clients in better ways. Now, we also help our clients with similar questions for IVD products, i.e. to evaluate the analytical performance of test kits.”
If you want to find out more about what our Biological Safety team can offer read more here or contact us today!
