Prosystem an NSF International Company of San Diego, CA at MEDICA 2018 in Düsseldorf -- MEDICA - World Forum for Medicine

Prosystem an NSF International Company

402 West Broadway, Suite 400, 92101 San Diego, CA
USA

This company is co-exhibitor of
Messe Düsseldorf North America

Hall map

MEDICA 2018 hall map (Hall 16): stand E10-9

Fairground map

MEDICA 2018 fairground map: Hall 16

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.17  Other medical services and publications

Our products

Product category: Other medical services and publications

Clinical Evaluation Report

The clinical evaluation report need to be provided for all medical devices without exception and shall be updated at regular intervals depending on their classification, sometimes annually, to keep the newest status. Evidence of safety, performance and clinical benefit is based on clinical data that could be obtained from various sources. The Guideline MEDDEV 2.7/1 Revision 4 offers helpful guidance on the content and implementation of the clinical evaluation report. Stricter, legal requirements are implemented with the validity of the Medical Devices Regulation 2017/745.

A special challenge is the approval of medical devices in the Chinese market. Again, a clinical evaluation is necessary for your registration. Furthermore, specific requirements are set by the Chinese regulatory authority, the CFDA (China Food and Drug Administration). The CFDA clinical evaluation report should be complied with the corresponding guidelines. Our specialists in this field are native speakers and have extensive experience in CFDA approval.

In addition, our processes ensure that the current regulations are met, when creating and updating clinical evaluation reports. Are your clinical evaluations still up to date? Take advantage of the expertise of PROSYSTEM GmbH and let us help you to create and update your clinical evaluation report. You also can visit our seminar and our experts will train you on the subject of clinical evaluation and advice you comprehensively. In this way, you gain valuable competitive advantages and accelerate your market access.

Our Clinical Evaluation services include:

  • Creation and update of clinical evaluations in German or English according to MEDDEV 2.7/1 Revision 4, Medical Devices Regulation 2017/745 or CFDA requirements
  • Evaluation of the clinical data. Identify if a clinical trial is necessary to obtain approval in the EU or in China.
  • Gap analysis according to medical device regulation 2017/745 or CFDA requirements
  • Implementation of the relevant processes and forms
  • Which marketing claims can be used?
  • Are all clinically relevant risks considered?
  • Database research of clinical experience data
  • Risk-benefit assessment
  • Conducting literature reviews
  • Preparation of procedural instructions and forms
  • Training your colleagues with training certificate

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Product category: Other medical services and publications

PROJECT MANAGEMENT FOR MEDICAL DEVICES

Projects in biomedical engineering are different! A variety of circumstances like national and international regulatory requirements, authorities having jurisdiction, notified bodies, customers, patients, users and third parties make the difference. You should only trust companies that feel at home in this market and that know the differences to others. Since it all depends on these fine differences.

Projects are our trade

Our specialists and project engineers relieve, support and advise you in all phases of your project through the acquisition of specialized tasks, such as project planning, risk management, control and documentation
We will work together with you the most effective development and regulatory strategies for your medical devices.
The many years of experience of the PROSYSTEM employees as well as broad knowledge of the biomedical engineering sector form the foundation of ourimplementation oriented consulting approach. We convince customers with performance: 80% of our turnover comes from follow up projects.

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About us

Company details

PROSYSTEM, an NSF International company, is a worldwide leading consulting and service company in biomedical engineering. The sustainability of our successful projects is the foundation of our longstanding customer relationships. Together with our customers we form the future of biomedical engineering by pointing out new chances as well as handling critical challenges. Our portfolio covers consulting, management of complex projects and interim management. It is our business to meet your special needs and to offer ideal solutions.

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