MedTech / IVD

Medical Devices consultancy

Support from concept to commercialization in compliance with MDR and IVDR

Our expert Medical Device Managers have hands-on product development experience in all phases of development and can provide you with tailored advice to support and accelerate your product development. We have worked for start-ups as well as global companies and understand your challenges. We can support you in discussions with your board and investors.

Our Medical Device Managers will work by your side to help you manage and execute your projects and ensure that all required steps in the process from concept to commercialization are taken at the right moment in time. By involving LINK Medical experts from various departments such as Medical Writing, QA, Biostatistics, and Clinical Development, we can create a team that provides the highest quality advice for your product. Our long-term experience with Notified Bodies enables us to provide you with advice on selecting the right Notified Body for your product and to support you while you are being audited. 

Regulatory strategy

Our Medical Device Managers evaluate your product and determine the classification. Additionally, we provide insights on the factors in your Intended Purpose that may influence your classification, and thus your strategy. We provide you with a comprehensive strategy and budget that will enable you to convince your stakeholders to support your further development.


Our team includes Medical Device Managers experts in QMS implementation. We have available templates to structure your QMS, and the structure has passed the scrutiny of various Notified Bodies. We can also perform audits of your quality management system. We also have regulatory experts that can help you to compile a Technical File that addresses all relevant topics and ISO standards that may apply to your Medical Device or In Vitro Diagnostic device. Furthermore, our broad experience enables us to provide valuable input to your Risk Management approach.

Clinical / Performance Evaluation

We write Clinical and Performance Evaluation Plans and Reports (CEP/CER, PEP/PER) that enable you to present a strategy to enter the market and to grow according to your commercial strategy. Whether it is a state-of-the-art literature search, a Clinical Investigation Plan or an Investigator Brochure, our team of Medical Writers deliver high quality that leads to approval.

We have Clinical Development experts that help you with study design, and that understand how study design can impact health economic assessment. We have in-house teams for biostatistics, eCRF development and data management. A multidisciplinary team is set up for your clinical study to secure the highest quality of data is made available for analysis.

Our Clinical Project Managers and Clinical Research Associates bring in many years of experience in clinical study management and monitoring for Medical Device and In Vitro Diagnostic.

LINK Medical is a full service CRO and regulatory service provider, which means that we deliver the full coordination of your study from design to submission to execution and compile the results in a detailed clinical investigation report.


CE-Mark & Commercialization

Our Conformity Assessments have helped many companies to pass several Notified Body audits. And we support you in putting the Unique Device Identification (UDI) in place and filing in the EUDAMED database.

Our post-market regulatory experts deliver services such as translations and proofreading of IFU’s and marketing materials. And for Post Market Clinical Follow-up (PMCF) and Post Market Performance Follow-up (PMPF) our Clinical Development team has all the right people on board. Furthermore, we offer translation services, readability testing and outsourcing.

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