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Regulatory Strategy

Ensure quality at the heart of your operations

Accelerate your speed to market with an effective regulatory strategy

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.

What is a regulatory strategy?

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.

Why is it important?

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.

How can we help you?

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.

Our services at a glance

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.

  • Regulatory strategy - TÜV SÜD’s regulatory strategy service enables manufacturers to develop a clear, comprehensive and efficient path for achieving regulatory approval for all types of medical devices in major markets around the world.
  • Mock Inspections according to 21 CFR 820 - TÜV SÜD can offer Mock Inspections according to 21 CFR 820 which helps medical device manufacturers to identify possible gaps within their quality management system, facilitating rectification before an official FDA inspection. This service is relevant to all manufacturers interested in improving compliance to 21 CFR 820 requirements including manufacturers already present in the American market and those seeking to enter.
  • FDA 510(k) third party review service - TÜV SÜD Product Service has participated in the FDA 510(k) third-party review program since its inception in 1996, and offers third-party submission reviews for over 600 devices. TÜV SÜD Product Service medical device experts maintain close contact with FDA reviewers to ensure that issues are promptly addressed, resulting in a more efficient review process and timely product clearance.
  • Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971, and conduct thousands of in-depth risk management audits each year. 
  • Other testing and certification services - TÜV SÜD can also provide compliance testing for active, non-active and in-vitro medical devices in accordance with other relevant regulations and standards, including IEC 60601-1 and electromagnetic compatibility (EMC).

Your benefits at a glance

  • Recognised medical device expertise - TÜV SÜD Product Service is one of the largest European Notified Bodies in the world. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD Product Service is recognised by regulatory authorities for its extensive experience with all types of medical devices.
  • Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards, allowing TÜV SÜD clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs. 
  • Single source solution - TÜV SÜD offers testing services for major medical device markets according to international standards and regulations.

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