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ISO 13485
Medical Device Certification
In the field of medical products, devices and components, regulatory requirements and customer needs regarding quality are becoming ever-more stringent. Legal manufacturers and their global suppliers are expected to pro-actively comply with the highest standards and regulations. Certification is needed before entering new markets or before customers place orders. ISO 13485:2003 is now the foundation for all regulatory requirements. Medical device testing and medical device certification are essential not only for companies who export but also for domestic sales.
Prove your Customer Commitment
Whether you are a small company or a multinational corporation, certification from SGS will show your commitment to the highest possible standards and form the basis of your medical device quality assurance now and in the future. Medical device certification also serves as a management tool to help improve your quality management systems and key processes.
ISO 13485:2003
Certification to the ISO 13485:2003 standard from an approved body is now a direct requirement for some markets, (Australia and Taiwan), an indirect requirement for others (Europe) or can form the basis of GMP compliance (US). Medical device testing is based on the ISO 9001:2000 standard with additional requirements relating to design, special processes, environmental control, traceability, documentation, records and regulatory actions. SGS certification to ISO 13485:2003 is usually offered with UKAS accreditation.
SGS ISO 13485:2003 certification is accepted by many countries and organisations such as the World Health Organisation (WHO).
SGS Assessments
ISO 13485 requires regular site audits which SGS conducts on a global basis. SGS has thousands of clients ranging from small manufacturers to multinationals. These companies produce low-risk devices through in-vitro diagnostic devices to the highest risk equipment and implants containing animal tissue or pharmaceuticals. Over time, SGS certification translates into increased performance and helps build commercial success in regulated markets.
Benefits of Medical Device Certification
Using SGS as your medical device certification partner brings numerous benefits:
- Not all certification is perceived to carry the same status. SGS medical device certification, whether to ISO 13485 or in combination with regulatory certification, will be viewed by your customers, distributors and authorities as a genuine commitment to the quality of your medical devices during the approval or bidding process.
- Most medical device manufacturers will eventually want to sell their products worldwide. The SGS policy of offering all approvals possible will help you achieve this objective.
- Regular assessments performed by SGS help you monitor and improve your management system and processes. This improves the reliability of your operations and products, ensures compliance with regulatory and customer requirements and increases financial performance.
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