Medical Device Project B.V. (MDProject) is an independent Consultancy Company active in the medical device field. We have expertise relevant for medical device manufacturers, suppliers, the distribution chain and users. Main focus of our activities are on the design and development of medical devices, implementing Medical Device Regulations, set up, writing and maintenance of Technical Dossiers and Design History Files, product and process risk management, software development, biological evaluation, scientific writing, clinical evaluation, validation of processes, quality management system (ISO 13485) implementation, auditing, training and coaching.
Meeting the rigorous regulatory demands for medical devices is paramount for successful market access. At MDProject, we offer comprehensive assistance for both non-active and active medical devices, ensuring compliance with global regulations such as EU MDR / IVDR and 21 CFR Part 820. Our expertise spans across various domains, enabling us to tailor your quality management system to align seamlessly with the ISO 13485:2016 standard, a pivotal foundation for compliance.
For non-active medical devices, we specialize in batch production, process validation, cleanroom environments, sterilization processes, clinical evaluation and biological safety. Our adept team diligently helps to construct technical documentation, while providing hands-on guidance to implement a robust quality management system. We navigate the complexities of EU MDR / IVDR and 21 CFR Part 820, ensuring your product aligns with stringent standards.
When it comes to active medical devices, we provide the same services considering the intricate provisions of the IEC 60601 series standards. Our proficiency spans across technical documentation development and practical support, helping you navigate the regulatory landscape with confidence. With our comprehensive services, your team receives tailored training and on-the-job support, equipping them to understand and fulfill the regulatory demands.
Explore our SERVICES, to uncover the depth of our experience and competences. For tailored insights into your specific needs, we invite you to reach out and engage in a conversation with us.
Our consultancy specializes in providing comprehensive guidance to developers of medical device software within the framework of the EU MDR / IVDR and in alignment with ISO 13485 and IEC 62304 standards. By leveraging our expertise in quality assurance and regulatory affairs, we facilitate a seamless integration of this pivotal regulation and standards into your software development processes.
Our adept team offers invaluable insights into designing and enhancing your quality management system, reviewing technical documentation, and ensuring that all facets of your software development adhere to the specified requirements. We are well-versed in interpreting and applying the provisions of EU MDR / IVDR, ISO 13485, and IEC 62304, safeguarding compliance and expediting your path to market approval.
With an unwavering commitment to precision and compliance, we empower you to navigate the complex landscape of medical device software development while upholding the highest standards of safety and efficacy. Collaborate with us to optimize your processes and ensure the realization of top-tier, regulation-compliant software solutions.
Are you provider of products or services to the medical device industry? And are your customers’ demands increasing? We provide you with the required knowledge to be able to manage your customer request optimally. This includes establishing compliant design processes and production controls, using ISO 13485:2016 as the blue print for your quality management system.
Our experience and competences are identified in SERVICES, you are welcome to contact us for information about your specific needs
Importers and distributors have a crucial role in providing medical devices towards the users. Throughout the world, several regulations are placing requirements on these so-called economic operators. They will need to ensure that the products are delivered, installed and used as indicated by the manufacturers. To be able to ensure that the requirements are met, establishment of a quality management system is strongly recommended. ISO 13485:2016 is used by our consultants to help economic operators to meet the regulatory requirements.
Our experience and competences are identified in SERVICES, you are welcome to contact us for information about your specific needs.
Specifically in the EU, healthcare institutes, such as hospitals and dentist, are being impacted by the new EU MDR. To understand the impact, MDProject consultants can provide training, set-up and support change programs within the hospitals to ensure that these new requirements can and will be met.
Our experience and competences are identified in SERVICES, you are welcome to contact us for information about your specific needs.
The mission of MDProject is to deliver specialized consultancy services for regulatory affairs and quality assurance, focused on the medical device industry. Our content and solution driven, experienced team offers pragmatic, hands-on services to guide our clients through product realization and registration processes, ensuring continuous market access.
We are a highly technical focused consultancy, understanding your products and therefore your challenges. We will ensure that your specific needs are addressed.
