Training brocure Q1/Q2 2023
The training brochure Q1/Q2 2023 is published! Six subscription training for QA and RA professionals. Check out our training page for more details.
21 November 2022
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.
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Your products need to meet the regulatory market access requirements. We help you to meet those requirements by establishing technical documentation and implementation of a quality management system. To be able to meet the requirements of the different regulations around the world, such as EU MDR / IVDR and 21 CFR Part 820, we use the international standard ISO 13485:2016 to tailor your quality management system to these requirements.
Furthermore, your product needs to meet many requirements that are identified in the regulations. Meeting these requirements requires technical knowledge that will explain regulatory demands for your specific product. We will help to build your technical documentation and will ensure that you can meet these requirements by providing hands-on support, write reports and train your team on the job.
Our experience and competences are identified in SERVICES, you are welcome to contact us for information about your specific needs.
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.
Mission and Vision
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.