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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.

Medical device

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 regulations that are relevant to your medical devices and 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 13485 and MDSAP
  • Regional regulations, including medical devices and in vitro diagnostic devices EU directives and regulations
  • Local regulations, such as those of Hong Kong, Japan (JPAL) and Taiwan (ROC)

Our certification programs cover:

  • Training on regulations 
  • Audits of your processes and systems against the requirements of the applicable standards or regulations
  • Issuance of certification upon the completion of a successful certification process

Our focus is on helping you achieve certification so that your product is not stalled by regulatory complications before getting to market and providing a high level of safety to patients and healthcare professionals. With an international network of specialists and a world class reputation for expertise and first class service delivery, SGS is uniquely equipped to assist with your MD and IVD regulatory certification requirements.