Instructor

Anna Sahlholm

Anna Sahlholm is employed at GBA Key2Compliance and has more than 15 years of experience from product and process development in close collaboration with research and within the medical device industry. Anna has worked with research, product development, strategic product management, clinical evaluations, processes for traceability, risk management, quality, and regulatory compliance for a variety of products.

Anna’s role at GBA Key2Compliance include training and consulting in clinical evaluations, project management, health economy, management systems according to ISO 13485 and regulatory matters.

Related courses to Anna Sahlholm

Design, Development and Regulatory Compliance for Medical Devices and SaMD

Learn how to apply design controls to ensure regulatory compliance for both hardware and software medical devices using agile development principles. This course covers ISO 13485, IEC 62304, EU MDR, FDA, risk management, SaMD, AI, and cloud-based technologies.
ISO13485, IVDR, MDR, Regulatory Compliance

ISO 14155:2020 – Good Clinical Practice for Medical Devices (GCP)

A practical approach to medical device clinical investigations according to ISO14155. How to plan, perform and document. Examples on what to focus on and which types of investigations to apply when, during your device development.
Online
Clinical development, Clinical investigations

Design and development of Medical Devices

A course to understand how to design and develop medical devices to ensure their safe and effective use.
Design Control

Medical Device Postmarket Surveillance – PMS

Learn the key requirements and how to maintain an efficient PMS system in compliance with the EU and US Medical Device regulations.
Online
Post market, Regulatory Affairs

Kvalitetssystemkrav för Medicinteknik

Förstå de centrala krav som måste vara uppfyllda för att utforma och förvalta ett kvalitetsledningssystem enligt regelverken i EU och USA.
General, Quality management and QA

Search

Search