Life Sciences Medical Devices
No matter what 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 quickly whilst ensuring compliance with the required regulations and standards.
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 9001, ISO 13485, EC Directive 93/42/EEC (MDD), EC Directive 98/79/EEC(IVDD), CMDCAS (Canada), PMD Act (Japan), INMETRO (Brazil), FDA Accredited Persons Program, Good Distribution Practice, with additional regulatory approvals for Taiwan, Hong Kong, Australia, Korea, Saudi Arabia 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 17025 accreditation.
Microbiological and Pharmaceutical Testing: Sterility, biocompatibility, bioanalytical.
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: Supplier audits, gap analysis audits, pharmaceutical GMP audits.
Let SGS facilitate your access to global markets and support your supply chain and risk management.
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.