Tag: medical device consultant


Understanding MDSAP

MDSAP (medical device single audit program) is an international program, which allows a single regulatory audit of medical device manufacturer’s QMS’ for the following regulatory agencies: • Therapeutics goods Administration (TGA) – Australia • Agência Nacional de Vigilância Sanitária (Anvisa) – Brazil • Health Canada (HC) – Canada • Food and Drug Administration (FDA) – US • Ministry of Health and Labour and Welfare (MHLW) – Japan The benefit of MDSAP, is one single quality system inspection that will encompass 5 markets versus having to complete 5 separate audits. One single audit......

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Why is it so important to review and update your regulatory strategy?

Formulating a well defined and researched regulatory strategy is vital for medical device and in-vitro diagnostic (IVD) companies. The regulatory world is constantly evolving, with Brexit and the introduction of the new MDD and further changes planned for the coming years, it is important that a regulatory strategy is reviewed and updated as new and updated requirements are identified. New requirements and/or updates could have a significant impact on existing or new products. Regulatory standards are used to assess the safety, efficacy and quality of medical devices throughout the product lifecycle. There’s......

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The CE Mark matters in medical markets

Selling any product into the European market can be simplified if a manufacturer can show that it complies with appropriate regulations. For medical device manufacturers, this compliance is vital.  Regulatory strategy planning is a critical step in the development and marketing of any medical device so it is important to understand the regulatory requirements of target markets, which can be quite different from country to country. It is equally important to have a clear understanding of the intended use, indications and claims for a device as these influence how to classify or......

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