EMpU is your medical device management consultancy for medical devices with derivatives of animal origin
In a more and more complex regulatory environment we assist with optimal solutions for:
- process development for biological tissues,
- regulatory support for MDR and FDA approval and registration,
- verification & validation planning and testing,
- development and validation of chemical sterilization procedures.
We have successfully provided our services to national and international medical device companies over the past years.
Animal Origin
We are specialized in navigating the intricate landscape of medical devices that utilize materials derived from animals. These materials play a crucial role in enhancing device performance, offering advantages over non-animal-based alternatives.
Key Issues:
- Materials of Animal Origin: Our portfolio includes devices that utilize animal tissues such as porcine/bovine heart valves, bone substitutes, and hemostatic agents. These materials pose unique challenges related to disease transmission.Our expertise extends to controls on sourcing, collection, handling, and validation of these materials. We work closely with manufacturers, ensuring compliance with regulations and risk management practices.
- Risk and Quality Management: We guide manufacturers in implementing robust risk and quality management strategies. Our goal is to prevent the spread of animal-borne diseases to patients. This involves risk analysis and suitable controls for:
- Bio-contamination: Animal-derived materials can carry pathogens, parasites, viruses, bacteria, molds, and yeasts. Proper risk analysis and management are essential to address these potential hazards.
- Bio-incompatibility: Ensuring that the materials do not cause adverse reactions in humans due to differences in biological compatibility.
- Transmissible Agents: The risk of transmitting infectious diseases (such as viruses, bacteria, and transmissible spongiform encephalopathy agents) must be thoroughly evaluated. Transmissible Spongiform Encephalopathy (TSE) underscores the importance of vigilance. We address TSE risks associated with animal tissues and recommend effective risk mitigation strategies.
In partnership with our clients, we strive to advance healthcare while safeguarding patient safety.
Company
ContactEMpU was founded in 2018 by Wilhelm Erdbruegger, a researcher and medical device professional with more than 20 years experience in development and certification of class III medical devices who has worked for various medical device companies in Germany and Switzerland. He is an expert in biological tissue process development for tissues primarily used in heart valves and inventor of several patents in this field The main topics of his work are releated to prolonged durability of heart valves and improved usability of transcatheter heart valve replacement (THVR) devices.
Wilhelm Erdbruegger studied Biology and Microbiology at the University in Münster, NRW and holds a PhD in Zoology of the University Münster as well as a MBA in Biotechnology and Medical Technology of the University in Potsdam, Brandenburg. He is author of various publications related to heart valve development and cardiovascular pharmacology in peer reviewed journals.
EMpU is part of a greater network of experienced medical device consultants covering a broad range of expertise and thereby creating benefit for the customers.
