medical device regulations, medical device market, medical devices regulations, medical device regulation Effective date: 1 OCT 2014 © TÜV SÜD AG | V-M/MHS/WEB/52.0/en/SG
Ensure quality at the heart of your operations
The timely and efficient registration of medical devices in key target markets is critical for successful product launches in the medical device industry. However, as different markets have different regulatory requirements, the registration of medical devices has its pitfalls. Indeed, even experienced regulatory affairs managers can find it difficult to keep track of constantly changing regulations.
Medical device manufacturers who consider the full range of applicable regulatory issues at the earliest possible stages of product development can more effectively plan the launch of new products. With an effective regulatory strategy, existing issues with the medical device can be identified and rectified earlier, avoiding potentially expensive and time-consuming corrective efforts at a later stage. Depending on the issues identified, an effective regulatory strategy can streamline product development and, in the most extreme cases, even prevent the need for a product re-design.
TÜV SÜD’s regulatory strategy service begins with an extensive questionnaire that investigates critical aspects of your medical device, from technology issues and intended use to considerations regarding quality management systems and intellectual property protections. Based on this data, our medical device specialists will equip you with the necessary information that will enable you to develop a comprehensive regulatory strategy that aligns with your product development timelines and budget. TÜV SÜD's specialists can also provide follow-up services (for example testing and 510(k) third party reviews) and meetings during the implementation phases of your regulatory strategy, and help you to address unexpected challenges.
Medical device manufacturers that fail to account for regulatory compliance issues early in the process are often met with unexpected surprises. Efforts to achieve compliance with regulatory requirements after the product development process has been completed can be a significantly more complex undertaking, and can even cause further product development efforts with lengthy delays.
TÜV SÜD manages the registration of medical devices all over the world (for example in Russia and Malaysia). Our medical device professionals and specialists are experts regarding national requirements applicable to medical devices in all key target markets. As such, we know the critical questions you have to ask to identify the gaps in your planning of an effective regulatory strategy. Our comprehensive and systematic approach to regulatory compliance makes it easier for medical device manufacturers to more accurately plan the resources and time required to achieve compliance. Our experts can also assist you to identify important milestones to be accomplished to avoid delays in your registration processes.
TÜV SÜD’s medical device specialists have extensive experience with all types of medical devices, and share their expertise through service on international standardisation committees addressing medical device safety issues. TÜV SÜD can also provide electrical safety testing, electromagnetic compatibility testing and environmental testing for a variety of medical devices.
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