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With consumers across the globe increasingly wanting to take control of their own health and well-being, demand for medical devices that are classified as consumer products is on the increase. At the same time, regulatory bodies are seeking to ensure the safety and reliability of these products, and businesses have to meet an increasingly complex list of regulatory requirements that change across different geographic markets.

SGS regulatory certification services have been developed to help you make sense of regulation that is relevant to your medical devices products and to help you achieve certification with as few complications as possible.

Our experts have in-depth knowledge of relevant regulations and how they are applied. We create certification programs that meet the specific business needs of your organization, taking into consideration your products and the markets you are trying to reach. We can help you achieve certification for international standards such as ISO,  for regional regulations such as EU Directives, USA Listing Mark, Canada Certification Mark and for local regulations, such as those in Australia, Canada (CMDCAS), Hong Kong, Japan (JPAL), Taiwan (ROC) and the US.

Our certification programs cover:

  • Training on regulations relevant to your circumstances
  • Audit of your processes and systems against the requirements of the applicable standards
  • Issuance of certification upon the completion of a successful certification process
  • Third party testing of materials or products, where necessary

Our focus is on helping you achieve certification as quickly as possible so that your product is not stalled by regulatory complications before getting to market. With an international network of specialists and laboratories, and a world-class reputation for expertise and first-class service delivery, SGS is uniquely equipped to assist with your regulatory certification requirements.