Service
CE Mark Regulation EU 2017/745 (Medical Device Regulation)
Support in the Medical Devices CE Marking Process
- Consulting
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
IPN has a multidisciplinary team, capable of providing complementary competencies and undertaking RTD, innovation, entrepreneurship and technology transfer activities. The Automatics lab's design and development process is certified under ISO13485 for Telemedicine and Telerehabilitation solutions. Additionally, our Clinical Investigation Partnership with hospitals across 9 EU countries allow us to offer a testing and validation platform and support the clinical investigation, usability, business validation are regulatory support for medical devices.
# AI; Artificial Agents; Robotics; Internet of Bodies; Secured Medical Devices
Digital Health/SmartHealth
eHealth Impact Test and Validation Unit Coordinator
Instituto Pedro Nunes
Project Manager @IPN-Incubadora
Instituto Pedro Nunes
Head of Business Development for Regulatory & Clinical Strategy
Instituto Pedro Nunes
Client manager
Instituto Pedro Nunes
Service
CE Mark Regulation EU 2017/745 (Medical Device Regulation)
Support in the Medical Devices CE Marking Process
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Service
Support in Submitting the Process for Certification by a Notified Body
Medical Device Regulation
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Service
Regulatory Roadmap/ Technical Documentation Gap Analysis
Medical Device Regulation and FDA Clearance
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Service
Support in the UDI (Unique Device Identification) Assignation Process
Medical Device Regulation and FDA Clearance
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Service
Identification of Pre-clinical Testing Requirements and Accredited Labs
Medical Device Regulation and FDA Clearance
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Service
Quality Management System IS0 13485:2016 and 21 CFR Part 820
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Service
Internal Audits of the System and/or Product
Quality Management System IS0 13485:2016 and 21 CFR Part 820
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Service
Coordination of Clinical Partnership
Clinical Investigation ISO 14155:2020 - Pilot Studies
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Service
Support in Clinical Investigation Documentation
Clinical Investigation ISO 14155:2020 - Pilot Studies
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Service
Clinical Investigation Research Management
Clinical Investigation ISO 14155:2020 - Pilot Studies
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Service
Key-Opinion Leader (KOL) Validation
Timely KOL validation by clinical experts through a systematic assessment will reduce the risk of failure in subsequent steps.
Client manager at Instituto Pedro Nunes
Coimbra, Portugal
Client manager at Instituto Pedro Nunes
Coimbra, Portugal