Life Sciences Medical Devices
No matter the size of your organization, SGS’s medical device testing, certification, audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market while ensuring compliance with the required regulations and standards and providing a high level of safety to patients and healthcare professionals.
As the world’s largest inspection, verification, testing and certification company, we provide clients with a market leading, global network of medical device offices, laboratories and experts. Operating in over 35 countries, we offer global and local solutions to meet your certification, testing, training and audit requirements. We offer virtually every global approval you need now or will need in the future.
Certification: ISO 13485, EC Directive 93/42/EEC (MDD) until May 2020, EC Directive 98/79/EC (IVDD) until May 2022, MDSAP, MDR* (EU) 2017/745, IVDR* (EU) 2017/746, PMD Act (Japan), INMETRO (Brazil), Good Distribution Practice, with additional regulatory approvals for Taiwan, Hong Kong, Korea, and others.
Electro-medical testing: Product safety and EMC testing to the full range of IEC/EN 60601 and IEC/EN 61010 series with CB, NRTL approval and ISO/IEC 17025 accreditation.
Microbiological and chemical testing: sterility, biocompatibility, microbial and polymer identification, container closure, environmental monitoring, extractables and leachables, endotoxin, cleaning and disinfection.
Other Testing: wireless/telemedicine, battery, RoHS 2, packaging.
Training: QMS/auditing, internal auditing, global regulations, sterilization processes, risk management, product safety/EMC, with public and in-house courses.
Auditing: Pharmaceutical GMP audits.
Let SGS facilitate your access to global markets and support your supply chain and risk management.
* Designation for MDR and IVDR still pending
When completing our enquiry form please select Industry-Life Sciences and start the “How can SGS help” box with the words “Medical Devices” to ensure a quick response from our experts.