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 global medical device regulatory space is becoming increasingly complex, making a well defined and researched regulatory strategy vital for medical device and in-vitro diagnostic (IVD) companies. With many changes planned for the next few years, a regulatory strategy ensures that you are well informed and aware of all existing requirements as well as any new or updated ones, which may impact the marketing of your device. We define the regulatory strategy as the ‘roadmap to market’ – because this describes the regulatory requirements that need to be addressed. There are a......
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