Certifying Your Medical Devices to International Standards is the Key to Global Market Success
Bangkok - Like all high technology sectors, the global medical device industry is characterized by rapid innovation cycles. From initial inspiration to market launch, medical devices go through many design and development phases. Throughout this process, manufacturers must live up to their responsibility to guarantee maximum patient benefits. This is where TÜV SÜD comes in- we can help manufacturers ensure their test procedures run smoothly, cost-intensive development times are reduced and compliance with safety and quality standards are ensured. Our experts also provide support services that extend beyond market launch such as monitoring production facilities, ensuring user manuals are comprehensible and providing training and education measures.
“With long-standing experience and expertise in the medical sector, TÜV SÜD is currently Thailand’s leading expert to help local device manufacturers enhance the quality and safety of their products and processes. With over 1000 customers worldwide in the medical device industry, Thai manufacturers have come to us to support them throughout the entire value chain- device safety, performance and fitness for use testing, inspections and certifications, clinical assessments, management system certifications, expert reports, international approval schemes, training courses and free sales certificates,” said Mr. Peter Porzler, Director, Medical and Health Services, TÜV SÜD Asia Pacific.
He added, “This reduces Thai manufacturers’ business risks, shorten their devices’ time-to-market and increase market access when they meet the necessary international regulatory requirements and standards. By leveraging on TÜV SÜD global accreditations, state-of-the-art laboratories and comprehensive testing equipment, local manufacturers can be assured of enhanced quality and safety of their products. They also gain customer confidence when their devices undergo 3rd-party, independent testing.”
“The After understanding what the customer needs, TÜV SÜD will tailor a 4-phase program to ensure facilitated and on-time product launches in targeted markets, higher efficiency, cost and time savings for the customer.
• Phase 1: Design & Development- According to the customer’s requirements, TÜV SÜD experts will help to insource the necessary skills and expertise with due consideration of international requirements, hold target group-specific user tests, and ensure the appropriate preliminary tests are undertaken during the entire design and development chain.
• Phase 2: Pre-approved Technical Tests & Clinical Trials- At this stage, TÜV SÜD experts will advise manufacturers at an early stage on the design verification tests required to later acquire the necessary certifications (for e.g. CE Mark), contract testing and assessment services, review clinical trial plans and collected data, and provide updated information on regulations to be complied.
• Phase 3: Product Testing & Certification - TÜV SÜD experts will help customers handle all product testing and certification procedures required for conformity assessments- including type testing and approval, design dossier examinations and consultation procedures for drug/device combination devices or devices incorporating materials of human or animal origin.
• Phase 4: Quality System Audit and Certification - At the last phase to international approvals, TÜV SÜD experts will proceed to assess and certify manufacturer’s Management Systems for compliance to ISO 13485, the European Medical Device Directive, the Canadian Medical Device Regulations, Japanese GMP and other global QMS requirements.
For more information on TÜV SÜD’s full suite of medical device services, please visit http://www.tuv-sud-psb.co.th/Healthcare.aspx.
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