ISO recertification of Bachem’s St. Helens site in the UK
- Bachem UK site successfully recertified to ISO13485 until 2027
- ISO13485 is the international standard for quality management in the medical device industry and ensures high-quality, safe, and compliant medical devices.
- Partnering with an ISO-certified CDMO offers many advantages.
ISO 13485 is an international standard that specifies the requirements for a quality management system in the medical device industry. This standard applies specifically to medical devices and covers the entire lifecycle of a product, from design and development to production, installation, and maintenance. It aims to ensure that medical devices are safe and effective for their intended use. In the peptide CDMO industry, ISO 13485-certification sets Bachem apart from other suppliers of raw materials for use in medical devices.
The benefits of partnering with an ISO-certified CDMO
Working with an ISO-certified CDMO such as Bachem offers many advantages for customers, partners and, ultimately, patients:
- Product quality assurance: Emphasis on quality management throughout the product lifecycle.
- Regulatory Compliance: Adapting to the regulatory requirements of the medical device industry.
- Traceability and documentation: Comprehensive documentation and traceability of processes, materials, and components throughout the supply chain.
- Risk Management: A robust risk management system must be in place.
- Consistency: Customers can expect consistent manufacturing processes.
- Continuous innovation: At Bachem, we live a culture of continuous improvement. Organizations certified to this standard are committed to regularly reviewing and improving their processes.
Bachem’s Center of Excellence for Custom Synthesis
Acquired in 1999, the St. Helens site is our center of excellence for manufacturing research chemicals. The site uses state-of-the-art automated equipment and can efficiently produce over 1000 peptides per year in quantities ranging from milligrams to grams, supporting customers in the in-vitro diagnostic (IVD) field with both products and a full range of related services.
Bachem’s Center of Excellence for Custom Synthesis
Acquired in 1999, the St. Helens site is our center of excellence for manufacturing research chemicals. The site uses state-of-the-art automated equipment and can efficiently produce over 1000 peptides per year in quantities ranging from milligrams to grams, supporting customers in the in-vitro diagnostic (IVD) field with both products and a full range of related services.
Understanding your needs to support you in all phases of your projects
With many years of experience of the ISO13485 medical device standard and certification to date, Bachem is ideally positioned to understand the needs of our customers in the manufacture of their IVD kits and to assist in all phases of the project.
