Clinical Investigation Procedure
- ISO 14155:2020 Compliant
- MDR EU 2017/745 Compliant
- ISO 13485:2016 Compliant
- Includes Multiple Forms
- MS Word Format
- Instant Download Digital File
Clinical Investigation Procedure OverviewThe Clinical Investigation Procedure defines the process to conduct clinical investigations per MDR (EU) 2017/745 and ISO 14155:2020.
Clinical Investigation Procedure - OverviewThe Clinical Investigation Procedure complies with ISO 14155:2020. The Clinical Investigation procedure includes detailed information on all aspects of clinical investigations. The product includes a CIP protocol and report template, Investigators' brochure (IB) template, investigation site initiation and monitoring forms, informed consent template and guidance on CRF construction.
Clinical Investigation Procedure - ComplianceThe Clinical Investigation Procedure is Medical Device Regulation (EU) 2017/745, ISO 14155:2020 and ISO 13485:2016 compliant.
For more information about our Clinical Investigation Procedure contact us at [email protected]
RELATED LINKS |
Clinical Investigation Procedure
|
Customer's also viewed
Clinical Evaluation Procedure Bundle
The Clinical Evaluation Procedure Bundle includes Standard Operating Procedures and Forms relating to Clinical Evaluations, Post Market Clinical Follow-Up, Post Market Surveillance and Clinical Investigations.
- MDR EU 2017/745 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MEDDEV 2.7.1, Rev 4
- MS Word Format
- Instant Download Digital Content
Medical Device Quality Management System | DESIGN PLUS
The DESIGN PLUS Quality Management System (QMS) is configured for companies engaged in research and development of medical devices but perform no manufacturing (Specification Developers). The Design Plus QMS system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 46 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System | MANUFACTURING
The Medical Device Quality Management System | MANUFACTURING product is designed for companies engaged in both product development and the manufacture of medical devices. The system is rich in content and provides detailed instruction governing research and development, manufacturing and post commercialization activities. The system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 60 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System | MANUFACTURING PLUS
The Medical Device Quality Management System | MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices seeking ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 72 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download