We offer innovative solutions for problems in the following areas:
Biocompatibility and toxicology in the context of medical devices (ISO 10993)
The toxicological evaluation and ascertainment of biocompatibility of medical devices is becoming increasingly complex due to changes in legislative environment and rapid amendments to standards.
Thanks to our experience in the test laboratory environment, we know the limitations and advantages of test procedures and can therefore propose targeted tests for your materials and products. This minimizes the amount of testing and time required and shifts the focus to the proper provisioning of documentation to regulatory bodies.
We accompany you step-by-step in the process of determining the biocompatibility of your product, whether in the development phase or re-evaluation, at every point:
- Gap analysis
- Review of test reports and test plans
- Biological Evaluation Plan (BEP)
- Toxicological evaluation of 10993-18 test reports or material lists
- Biological Evaluation Report (BER)
- Consultation and integration of requirements of the regulatory environment (MDR/REACh, FDA, etc.)
- Expert statements and training courses
Our clients range from start-ups and research institutions to medium-sized companies and major international corporations.
Development and review of reprocessing instructions (ISO 17664)
Creating standard-compliant reprocessing instructions (in accordance with ISO 17664-1 or ISO 17664-2) can either be carried out in the context of a revision, taking into account existing instructions for your product or comparable products, or if no previous IFU exists, as a de novo set of instructions.
Our experts possess many years of experience in the preparation of such reprocessing instructions and are involved in the development and updating of the relevant standards at the national level. Our team thus combines many years of experience in the field of reprocessing validation for numerous diverse medical devices, from non-critical Class I products to Class III implants, as well as devices that place the highest demands on the reprocessing procedures due to their characteristics (e.g. endoscopes or minimally invasive instruments), as well as an understanding of the requirements for the relevant formulations in the instructions.
When selecting products to form product groups, from which a "worst case" instrument is then selected, it makes sense to involve validation experts in the decision-making process at an early stage of the selection process in order to streamline the subsequent validation tests, reducing testing costs and decrease approval costs by unnecessarily increasing the number of product families. Our experts will be happy to help you.
On-site inspections and training courses for reprocessors (ISO 15883)
The requirements for hygiene in the medical sector are demanding and anchored in various legal regulations. Compliance with these regulations is verified by regular practice inspections. We offer professional support for your hygiene management so that you are optimally prepared.
Through targeted measures, such as on-site inspections and staff training, we help you to ensure and maintain the standard of hygiene in your daily operations, in order to ensure patient safety and minimize infection risks.
- Hygiene monitoring in AEMP and private medical practices
- Practice-oriented staff training
- Hygiene workshops
- Development and updating of hygiene plans
- Support with certification, external hygiene audits and official inspection
Questions? Please do not hesitate to contact us by e-mail or telephone.
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