Clinical Evaluation

Service content

According to MEDDEV 2.7/1 rev.4, any medical device installation and update must be done to solve any medical device problem. MEDDEV 2.7/1 rev.4 revision, which lists the specifications for the preparation of detailed clinical evaluations, has also increased the requirements for the clinical treatment of medical devices. Also 2017/745 Medical Devices Laboratory (MDR), review of risk class, European clinical evaluation and implementation consultancy. But the same will happen after the hospital emergency department (PMCF).

The best problems in this list are usually as follows:

• There is no comprehensive component comparison or template for this.
• Insufficient staff or limited resources
• Difficulties operating in the field of data science
• A multilingual ...
• Problems with data payment / evaluation in the latest technology
• Problems with determining the intended use or a very narrow range of intended use
• Some problems with the clinical evaluation system of PMS (Post-plan follow-up) / PMCF (Post-plan follow-up) results

As a result of our experience in product groups and our communication with various notified bodies to comply with the requirements of MEDDEV 2.7/1 rev.4 and the Medical Device Regulation 2017/745 (MDR), we define a fast and convenient way. What services do we offer in this regard:

Review of templates for compliance with the current regulation

Technical support for the preparation of a successful clinical evaluation

Advanced feedback opportunity implementation of the clinical evaluation

Assistance in preparing a plan for the clinical evaluation (CEP)

Assistance in preparing the post-market clinical follow-up (PMCF) plan

You will be in constant contact with your computer to ensure a correct accommodation in time. You will be kept constantly informed about the progress of the project and any potential problems. You can communicate personally with the clinical assessor.