Demonstrate compliance with regulations with product design dossier for medical devices
In most jurisdictions, the approval of high-risk medical devices usually requires manufacturers to provide regulatory authorities with detailed technical documentation demonstrating compliance with all applicable regulations and requirements. Depending on the type of medical device involved and the degree of risk associated with the device, required technical documentation can include testing reports, clinical and/or biological evaluations, and risk management assessments. This technical documentation, referred to as a product design dossier for high risk products, is thoroughly reviewed by relevant technical experts, such as physicians, biologists, microbiologists and other specialists, during the final review and approval process.
The preparation and certification of a product design dossier is a requirement for medical device manufacturers seeking to meet the essential requirements of the European Union’s (EU’s) directives and regulations for active implantable medical devices (AIMDD), in-vitro diagnostic medical devices (IVDD), and medical devices (MDD). The review and certification of the design dossier by EU Notified Bodies and other regulatory officials typically occurs after a lengthy and expensive product design and development process. Therefore, it is essential that the design dossier fully and effectively addresses all of the technical and safety issues mandated under the applicable regulations.
A poorly developed design dossier, or a design dossier that fails to address all of the applicable regulatory issues, can result in a delay in the product approval process, or even a rejection of an application for medical device approval. Device manufacturers are well advised to have their design dossiers reviewed and certified by a reputable, independent third-party with extensive knowledge of applicable regulations and experience in assembling the technical documentation necessary for prompt and efficient regulatory review and approval.
Why choose TÜV SÜD
TÜV SÜD Product Service is an EU Notified Body and can conduct detailed design dossier reviews and issue design examination certificates in accordance with all EU directives concerning medical devices. In addition, TÜV SÜD Product Service has a global staff of medical device experts, with over 400 international specialists located in major markets around the world. These specialists are supported by TÜV SÜD Product Service’s own Clinical Centre of Excellence and foreign affairs department, and a scientific advisory board comprised of scientists and physicians from the leading universities and healthcare centres.
Achieving regulatory compliance for drug/device products
- Design dossier review and certification - TÜV SÜD Product Service is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices. TÜV SÜD Product Service can review design dossiers for medical devices and issue design examination certificates in accordance with the EU’s directives for all medical devices: IVDD for in-vitro diagnostic medical devices, AIMD for active implantable medical devices as well as MDD for medical devices.
- Expedited and Flexible Design Dossier service - Having a reputable Notified Body examine your design dossier means you can be assured your documentation is examined against the necessary regulatory requirements. Reduce the examination period and potentially accelerate your time to market with our new service.
- Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
- 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 audits covering risk management each year.
- GLP-compliant biocompatibility testing and biological evaluation - TÜV SÜD laboratories conduct biocompatibility tests in compliance with GLP Principles.
- Microbiological testing services - TÜV SÜD Product Service conducts microbiological tests for medical devices such as bioburden, sterility and endotoxin LAL tests, etc.
- Chemical testing services - TÜV SÜD Product Service is capable of providing chemical characterisation services for medical devices and components, as well as services for analysis for extractables/leachables and chemical residues. TÜV SÜD Product Service also provides contamination diagnosis services and shelf-life studies.
• Mechanical and physical testing services - TÜV SÜD Product Service conducts mechanical strength tests and physical tests. Frequently tested products include gloves, condom and packaging materials.
- 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.
- Other testing and certification services - TÜV SÜD Product Service can conduct compliance testing for 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 the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD Product Service is recognised by regulatory authorities around the world 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 clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
- Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD 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 standards and regulations applicable to medical devices.
- Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.
- Expert partnership - TÜV SÜD Product Service has a long record of technical and regulatory expertise for medical devices, and is a trusted partner to companies ranging from global manufacturers to regional and local research and development firms.