SWOT Analysis
Strength: Third-party certification helps manufacturers comply with regulations and gain user trust. It also simplifies the approval process.
Weakness: High costs associated with certification processes especially for new and small manufacturers.
Opportunity: Growing medical technologies in developing nations have opened up new markets for testing service providers. Continued regulatory reforms also create more opportunities.
Threats: Uncertified products from less compliant regions increase compliance risks. Delays in certification can impact new product launches.
Key Takeaways
The Global Medical Device Testing And Certification Market Growth is expected to witness high, exhibiting CAGR of 4.3% over the forecast period, 2023 to 2030, due to increasing regulatory requirements.
North America dominates the market currently owing to stringent MDR and FDA norms for approval. Asia Pacific is expected to grow at the fastest pace during the forecast period with the liberalizing regulatory environment in countries like India, China and Japan.
Key players operating in the medical device testing and certification market are Medistri SA, BSI Group, Ente Certificazione Macchine, GMED, IMQ Group SRL, TOXIKON, TÃœV SÃœD, WuXi AppTec, Pace Analytical Services LLC, Gateway Analytical LLC, Boston Analytical, Bureau Veritas, UL LLC, TUV Rheinland, SGS SA, Intertek Group PLC, Eurofins Scientific, Element Materials Technology, Dekra Testing and Certification GmbH, and Institute for testing and Certification Inc., among others.
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