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Regulatory Consulting: Identification of Pre-clinical Testing Requirements and Accredited Labs

Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: 487f9c1a-af9e-4631-b182-093726544927

Service Description

IPN provides expert guidance in identifying the applicable pre-clinical tests required for medical devices, ensuring alignment with regulatory standards and facilitating a seamless pathway to market. The focus is on determining the specific tests based on the unique characteristics of the device, such as whether it is sterile, active, implantable, or software-based. Examples of pre-clinical tests include electrical safety and electromagnetic compatibility (EMC) evaluations, biocompatibility assessments (e.g., cytotoxicity, sensitization, and irritation testing), cybersecurity analysis, sterilization and cleaning validation, microbiological tests (e.g., bioburden and sterility), and stability or shelf-life studies. Additionally, IPN’s team assist in identifying accredited laboratories with proven expertise to conduct these tests, guaranteeing reliable and regulatory-compliant results.

Keywords: pre-clinical testing
Offerings: Technological Solutions & Documentation Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.)
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Country Portugal
Published Email medicaldevices@ipn.pt
Billing: per hour
Full Price €85-150 EUR
Reduced Price €0-120 EUR
Pricing Detail

depending on seniority

Operational Details

Service Inputs 1- Device description and general information.
Service Outputs lab proposal
Certification Support CE Marking (MDR, IVDR)