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Our Services

Discover a comprehensive range of specialized services to support your medical device projects, from monitoring legislation and technical standards, to technical documentation and quality management system implementation, to a comprehensive regulatory strategy.

 

Our team of experienced professionals is committed to guiding you every step of the way and ensuring your success in the dynamic world of medical devices.

Market Access

We support manufacturers and distributors to enter the market quickly and efficiently, including securing reimbursement from public health insurance. Together we identify opportunities and barriers to unlock the potential of your medical devices. We look for the right positioning of your device in the system. We prepare BIAs and pharmacoeconomic analyses as required. We work closely with KOLs and professional societies.

Conformity Assessment

We prepare technical documentation for medical device manufacturers and guide them through the conformity assessment process. From pre-clinical assessment, biocompatibility assessment, risk management documentation to complete clinical evaluation documentation. For start-ups, we usually prepare documentation on a turnkey basis. We have in-house experts for all parts of the technical documentation.

IVD Medical Devices

We have specialists in the field of in vitro diagnostic (IVD) medical devices. We provide comprehensive support for manufacturers preparing for IVDR CE-marking and in particular certification by a notified body. We also support manufacturers in the area of functional competence assessment, from documentation of scientific validity, analytical function to demonstration of clinical function.

Software

Software manufacturers have very specific starting conditions. We guide developers of standalone software (SaMD) through the challenging CE marking process from qualification and classification to clinical evaluation. From previous projects we already know what usually represents a problem and misunderstanding. We can extract the best from the specifics of software design and development and build on the advantages.

Clinical Investigation

We provide clinical investigation for CE-marking of medical device. From clinical investigation design, basic statistical calculations, synopsis, to clinical trial plan, investigator's brochure, CRF and other documents to complete ddossier for clinical investigation approval. We also perform the monitoring of the clinical investigation and of course the statistical processing and writing of the final report.

Postmarket Clinical Follow-up

The planning and implementation of PMS activities are an integral part of the responsibilities of medical device manufacturers. We prepare PMS plans for manufacturers. Together with manufacturers, we actively collect market feedback and statistically evaluate it. The PMS evaluation includes an advanced methodology for monitoring and evaluating trends. 

Postmarket Surveillance

We provide clinical investigation for CE-marking of medical device. From clinical investigation design, basic statistical calculations, synopsis, to clinical trial plan, investigator's brochure, CRF and other documents to complete ddossier for clinical investigation approval. We also perform the monitoring of the clinical investigation and of course the statistical processing and writing of the final report.

Law Services

Legal services for our clients are provided by our sister law firm Porta Medica Legal. The Porta Medica Legal has long specialized in the field of medical devices and related areas of law. The law firm shares communication office spaces with Porta Medica, which simplifies intensive cooperation on joint projects. We are therefore able to provide legal representation in administrative proceedings and lawsuits, or the processing of legal opinions through our business friends.

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