Cardiovascular medical devices
- 1. Your challenges Cardiovascular medical devices such as artificial heart valves, coronary stents, endovascular grafts and angioplasty balloon catheters save countless lives each year and can dramatically improve the quality of life of millions of people. As the worlds population enjoys an ever-increasing life span, the global market for cardiovascular devices is expected to reach 121 billion (USD) by the year 2024. This continued growth offers significant opportunities for medical device manufacturers. However, the design, development and manufacturing of advanced implantable cardiovascular devices and other high risk medical devices is a complex, time-consuming and investment-intensive process for device manufacturers. New technologies must be identified and then evaluated and tested to determine their safety and effectiveness. Unexpected findings can set back the development process by months or even years. Further, given the greater degree of risk that they pose to patients, cardiovascular devices are also subject to significant review and oversight by medical device regulators in most major jurisdictions. In the EU, for example, implantable cardiovascular devices, which are regulated under the EU Directive on medical devices (93/42/EEC), will soon be expected to meet the more stringent requirements of the new EU medical device regulation (MDR). The expected changes include the reclassification of certain cardiovascular medical devices used in contact with the heart or the central circulatory system, more rigorous requirements for clinical evaluations and investigations, post-market surveillance and an increased scrutiny from national authorities and EU commission in the pre-market and post-market phases. For manufacturers of cardiovascular devices, overcoming these and other challenges require both in-depth technical knowledge and extensive regulatory experience. Cardiovascular Medical Devices Assessing the Safety of Cardiovascular Medical Devices. Choose certainty. Add value. TV SD
- 2. These challenges can be especially daunting for small and medium-sized companies, who constitute the majority of medical device manufacturers. How can we help you? TV SD is the worlds largest EU Notified Body for the full scope of medical devices covered by the relevant EU directives and regulations. We are also a leading global management certification body for quality management systems, including management systems applicable to the manufacture of medical devices. This unique combination of experience makes TV SD ideally suited to address the needs of medical device manufacturers seeking to achieve or maintain compliance with medical device requirements in the EU and other major markets around the world. TV SD bases its success in the cardiovascular field on the vast technical, clinical and regulatory expertise of the staff. Over twenty experts are dedicated to high risk cardiovascular devices, with expertise ranging from the technical to the clinical aspects and in specific fields covering tissue of animal and human origin, absorbable devices and medicinal substances. As predictability is paramount for our customers, our team of project managers provide assistance and support on all activities covering conformity assessment, ensuring resources are used efficiently and project timelines are scrupulously met. TV SDs services for cardiovascular and other high risk medical devices include: Technical documentation review - TV SD reviews the technical documentation for the device according to the requirements applicable to high risk devices, and issues the required product certificate following the completion of a positive assessment. The reviews are conducted by specialists with vast experience in the specific cardiovascular devices. Quality system auditing TV SD performs a quality system audit consistent with regulatory requirements, and can issue a Quality Management System certificate following the completion of a positive assessment.
- 3. Testing services TV SD provides compliance testing for high risk implantable medical devices in accordance with relevant regulations and standards. Assessments are based on witness testing conducted on the applicants premises. Clinical services TV SD Clinical Centre of Excellence comprises a number of clinicians trained on medical devices regulations and fully dedicated to clinical reviews. The unrivalled in- house clinical expertise covers the areas of heart surgery, interventional cardiology, electrophysiology, neurovascular surgery and many others. The direct access to the clinical reviewers allows TV SD to offer high quality and fast clinical reviews, that can be tailored to the specific product or customer needs. Market approvals and certification The regulatory requirements are often complex and vary between regions. TV SD has in-depth knowledge and experience of the key medical device markets around the globe to help you navigate the regulatory requirements and obtain the necessary approvals for your medical devices. Your benefits Recognised medical device expertise - TV SD is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and an in-house Clinical Centre of Excellence, TV SD is recognised by global regulatory authorities for its extensive experience with all types of medical devices. Predictability TV SD understands how predictability is key for the successful development and placement of a medical device on the market. That is why we offer clear timelines that can be tailored to the specific project needs and employ project managers dedicated to guarantee timelines are successfully met. Active involvement in standards development and implementation TV SD technical professionals are actively involved in standards development activities related to all types of medical devices, and participate in key standards committees. TV SD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on medical device standards and regulations.
- 4. 2017息TVSDAG|V-M/MHS/21.0/en/SG TV SD AG Westendstr. 199, 80686 Munich, Germany +49 89 5791-0 medicaldevice@tuv-sud.com www.tuv-sud.com/medicaldevice Single source solution TV SD offers a full range of review and testing services for high-risk medical devices as required by regulators in the EU, the U.S. and other major medical markets around the world. Expert partnership TV SD is a trusted partner to companies ranging from global manufacturers to regional and local start-up companies. Why choose TV SD? TV SD offers a complete range of testing, certification and auditing services to manufacturers of medical devices, including high risk implantable devices, helping them to manage risks and to protect and promote the health and safety of patients. Our global network of more than 500 dedicated medical health and services professionals include noted scientists and physicians recognised as authorities in their respective fields. These capabilities make TV SD the preferred single source for worldwide compliance with medical device regulations. Represented in over 1,000 locations worldwide, TV SD has an unsurpassed track record of meeting expectations of our client companies. The TV SD brand and our distinctive blue octagon mark are instantly recognised around the globe as symbols of quality and safety, and will increase customer confidence in your brand. Related services TV SD provides the following related services: Global approval of medical devices (foreign affairs) ISO 9001 Quality management system certification ISO 13485 Quality management system certification for medical devices Medical device market assessment Testing and certification for regulatory approval