Clinical Approval

Preclinical and clinical evaluations

We ensure the relevant qualification and competence to perform the clinical evaluation for you:

  • Analysis of the degree of innovation and relevant clinical risks of your products.
  • Feasibility studies prior to product development
  • Identification and evaluation of equivalence products – also for 510(k) procedures at the FDA
  • Preparation of a clinical evaluation plan and a strategy for market approval
  • Execution of the clinical evaluation according to MEDDEV 2.7/1 Revision 4 including preparation of the clinical evaluation report (CER)
  • Scientific literature search for the planned clinical application (indication/prevalence/state of the art in therapy and diagnosis)
  • Scientific literature search on equivalence products
  • Assessment of relevance (PICO) and methodological quality of the identified clinical data
  • Inclusion and evaluation of post-market surveillance data
  • Sound advice on the decision on the need for a clinical trial
  • Analysis of data and assessment of compliance with essential requirements (safety, performance, benefit/risk, side effects)

Clinical tests/studies

Our experienced CRO consultants organize for you and support by:

  • Formulating the objectives and hypotheses of a clinical trial/study according to EN ISO 14155
  • Conducting various types of studies (PMCF, IIT, pivotal studies, reimbursement studies, etc.)
  • Preparation of the necessary technical (minimum) documentation
  • Determination of test location and interfaces
  • Drafting of contracts and organization of insurance contracts
  • Obtaining the initial approval for the clinical trial
  • Project management of the clinical trial including budget management
  • Continuous monitoring as well as support and coordination of interfaces
  • Ensuring trial documentation, data management and data protection
  • Monitoring compliance with regulatory requirements
  • Evaluation of data from clinical trials according to statistical, biometric and other aspects
  • Preparation or review of the study report
  • Medical writing including relevant data, regulatory requirements and current formats

Post Market Surveillance (PMS), Vigilance, Post Market Clinical follow-up (PMCF)

We provide evidence of the safety and benefits of your medical device by:

  • Conducting annual market surveillance with schedule monitoring.
  • Analyzing the clinical evaluation, the risk management files and the usability
  • Engineering files for timeliness
  • Collecting, evaluating and reporting incidents
  • Preparation of “Field Safety Notice (FSN)”, “Field Safety Corrective Action (FSCA)” plan (Article 89 MDR).
  • Post-market surveillance report in accordance with Article 85 MDR.
  • Preparation and maintenance of the report on safety (“PSUR”) Article 86 MDR.
  • Scientific literature search as a continuation of the clinical evaluation regarding new evidence from the literature and regarding safety and benefits for the product being evaluated
  • Research on current guidelines from professional societies and information from authorities
  • Analysis of incidents reported to the manufacturer regarding the product as well as comparative products according to MEDDEV 2.12-1
  • Market surveillance research via international databases
  • Risk assessment with regard to reported incidents
  • Support for the decision on the necessity of post-market clinical follow-up studies