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Clinical Evaluation of Prototypes

Consulting
Pricing/Discount Options: Call #2
Unique Identifier: 800d5f92-eec7-45ee-9672-f254141edad3

Service Description

This service provides clinical testing and evaluation of medical device prototypes or healthcare technology solutions in real-world settings. It assesses functionality, safety, usability, and performance under clinical conditions, gathering essential data for further development and regulatory approval. Clinical evaluations are conducted on-site in healthcare environments by trained teams who manage setup, monitoring, and assessment according to standardized protocols, offering detailed reports on clinical performance, usability, and safety. Keywords: prototypes, real-world testing, medical device prototypes, testing

Offerings: Ethics & Regulatory Affairs Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Development of conformity evaluation standards, protocols & tools Clinical Investigation Support (coordination, design, feasibility, documentation,compliance, operations support, etc.)
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Provider & Contact

Provider Country Slovakia
Published Email tef@unm.sk
Billing: per hour/person
Full Price €270 EUR
Reduced Price €200 EUR
Pricing Detail

The average cost for service delivery, including all expenses (personnel, operational costs, equipment, and overhead), is estimated at EUR200 per person-hour. This includes: Personnel Costs: EUR70 (average salary per hour for skilled personnel, accounting for expertise in clinical evaluation) Equipment and Operational Costs: EUR90 (includes specialized medical equipment, testing tools, facility use, and utilities) Overhead Costs: EUR40 (administration, insurance, compliance costs, and other indirect expenses)

Operational Details

Service Inputs Technical documentation for the medical device (intended use, technical specifications, user manual, risk analysis, etc.)
Service Outputs Clinical evaluation report detailing performance, safety, and usability outcomes.
Dependencies & Restrictions MDR
Certification Support MDR 2017/745 and, if relevant, MDR 536/2014 for drugs
  • MDR 2017/745
  • MDR 536/2014 for drugs
Service Standards IHC GCP, MDR 2017/745 (and MDR 536/2014 for clinical drug testing)
  • IHC GCP
  • MDR 2017/745