Webinar – ISO 13485 peptides for IVD medical devices

Bubendorf, Switzerland: – The latest webinar from Bachem, the leading CDMO for peptides and oligonucleotides manufacturing, explains the importance of ISO 13485 certification for peptides to assure quality and safety for in-vitro medical device diagnostic applications.

The one-hour free-to-register webinar ‘Peptides with ISO 13485: Gold Standard for Medical Device Safety’ will be hosted on the Zoom platform on Tuesday June 24, 2025, commencing at 1700 hrs. CEST (UTC +2).

Medical device demands

The session will discuss special requirements for peptides that are used as critical raw materials for in vitro diagnostics (IVD) to measure the presence or concentration of a biomarker molecule that indicates disease.

Since quality and safety are paramount concerns in all aspects of the medical device industry, it is crucial to have a reliable and trusted supplier of critical raw materials that can demonstrate the ability to implement robust manufacturing processes, provide full traceability and documentation, and adhere to industry standard change control practices.

Bachem’s Centre of Excellence for Research Chemicals in St. Helens, UK, has been ISO 13485 certified to manufacture peptides as critical raw materials for medical devices since 2017 and is perfectly placed to partner with manufacturers commercializing peptide-based IVD kits.

Expert speakers

The webinar will be presented by a panel of three experts who will explain different aspects of how Bachem ensures that the peptides it manufactures for use in medical devices meet the stringent requirements of ISO 13485.

• Bachem UK Site Manager Dr. Iain Pritchard recently celebrated his 20^th Anniversary with Bachem (UK) Ltd, joining in 2004 as a Chemist in the Manufacturing (Upstream) Group, rising to Group Leader in 2006 and Director of Production in 2013, after completing his PhD studying the effects of Peptide YY analogues on appetite. Iain was appointed St. Helens Site Manager in July 2024.
• QMS Manager Joanne Capener has become an expert on assuring quality in IVDs in Cancer Diagnostics and Class Ila Medical Devices over the course of a 30-year career as a Quality Assurance specialist and lead auditor as well as a group leader for Health, Safety and Environment (HSE). Since joining Bachem in 2020, Joanne’s responsibilities have included ensuring that the company meets the highest standards of quality and safety. She is a certified ISO 13485 Lead Auditor and holds a NEBOSH qualification for health and safety.
• Sales Manager Custom Synthesis Daniel Yasini is a graduate in Organic Chemistry from the University of Milan and has specialized in process development of small molecule synthesis. As Bachem’s Sales Manager for Custom Synthesis. Daniel is responsible for small-scale, non-GMP peptide sales for Bachem UK, ensuring the highest industry standards are met.

Registration for the webinar is free of charge and can be completed online (see Resources).

About Bachem

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. The company, which has over 50 years of experience and expertise, provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services.

Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange.

For further information, see https://www.bachem.com

Resources

Click on Bachem Webinar: Peptides with ISO 13485: Gold Standard for Quality and Safety for further details and online registration.