• Other sectors

Clinical Evaluation Plan and Report Training

The requirements for clinical evaluations have increased over the years, and this will not change with the upcoming new regulation on medical devices. This course focuses on the applicable standards and guidelines, how to conduct literature searches and plan clinical evaluations, the report, and the feedback system.

• Other sectors

Design Control for Medical Devices

The need to establish process descriptions and processes interrelations are mandatory within the ISO 13485 and also a goal for effective Quality Management Systems. Many processes are working close to each other and there are possibilities to use those interfaces and avoid creating too many documents and still fulfill the requirements.

• Other sectors

MDR training E-Learning

A one-day e-Learning course covering the differences between Medical Device Regulation EU 2017/745 compared to the Medical Device Directive.

• Other sectors

Introduction to biocompatibility for medical devices

This training will provide participants with an insight into biocompatibility, risk-based approach ISO 14971:2019, on the ISO 10993-1 and ISO 10993-18 standards.

• Other sectors

Introduction to IVDR EU 2017/746 In Vitro Medical Device Regulation Training

The In Vitro Medical Device Regulation (2017/746) entered into Force in 2017 and has date of application May 26, 2022. This course provides a knowledge of the requirements of the regulations including the requirements for Technical Documentation and Quality system requirements.

• Other sectors

Introduction to MDR EU 2017/745 Medical Device Regulation

The revised Medical Device Regulation (2017/745) entered into Force in 2017 and has date of application May 26, 2021. This course provides a knowledge of the requirements of the regulations including the requirements for Technical Documentation and Quality system requirements.

• Other sectors

IRCA Certified ISO 13485:2016 QMS Lead Auditor Training for Medical Devices

This intensive ISO 13485 lead auditor course is a key requirement for becoming a registered Lead Auditor. Achieve an internationally accepted CQI/IRCA (Charted Quality Institute - International Register of Certificated Auditors) registered certificate.

• Other sectors

ISO 13485:2016 and Medical Device Regulation (MDR) Internal Auditor Course

You will learn the principles and practices of effective quality management process audits in accordance with ISO 13485:2016, the MDR and ISO 19011:2018. You will be taken through the entire audit process from planning the audit to reporting and follow up on non-conformities.

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ISO 13485:2016 Foundation Course

This course clarifies ISO 13485:2016 requirements and interpretations. Organizations that need to show evidence that they can provide medical devices which consistently meet customer and regulatory requirements will benefit from understanding ISO 13485.

• Other sectors

ISO 13485:2016 Internal Auditor Course

This internal auditor training course you will learn the principles and practices of effective quality management process audits in accordance with ISO 13485:2016 and ISO 19011:2018.

Løft kvaliteten med Process FMEA

Formålet med dette kursus er at give deltagerne en grundlæggende forståelse af Failure Mode Effects Analysis metoden (FMEA), som anvendes til at identificere og analysere potentielle fejl i produkter og processer. Kurset giver dig værktøjer til at forbedre kvaliteten og pålideligheden af dit arbejde med kvalitetsforbedringer i processer og produkter.

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MDSAP - Medical Device Single Audit Program

This course pack is designed to give you a detailed understanding of the medical device single audit program.

• Other sectors

Person Responsible for Regulatory Compliance (PRRC)

You will learn what you need to know about the role as PRRC, which is mandatory for Medical and In Vitro Diagnostic Device Manufacturers. We will get knowledge of what the role covers and how this role should be implemented from a regulatory perspective.

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Post Market Surveillance

This course will give an introduction to the regulations and guidance on PMS (plan and report) as well as the process interfaces.

• Other sectors

Risk Management ISO 14971:2019

This course will give an overview of the standard, the process and the tools. The process interface and the resource needs will be part of the course along side a workshop on risk analysis.