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Clinical Investigation Research Management

TEF-Health Service
Physical Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: 54d5e1e9-d2e4-4fb6-ba5e-8d96583003ea

Service Description

Supporting clinical researchers in managing patient recruitment, monitoring the research, and data collection according to ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice

Offerings: Ethics & Regulatory Affairs Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Testing Clinical (investigation, trial, etc.) Development of conformity evaluation standards, protocols & tools Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support, etc.) Testing Facility Real-World (ER, OR, ICU, office, ambulance, ward, patient home, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)
Provider Country Portugal
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Billing: per hour
Full Price €85-150 EUR
Reduced Price €0-120 EUR
Pricing Detail

depending on seniority

Operational Details

Certification Support CE Marking (MDR, IVDR)
  • CE Marking
Service Standards ISO 14155:2020; MDR EU 2017/745
  • ISO 14155
  • MDR EU 2017/745

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