Clinical Evaluation and Investigation for Medical Devices: ISO 14155 and ISO 18969

I dette kursus lærer du den integrerede tilgang til clinical evaluation process og dens vigtige forbindelser til risk management, R&D og udvikling, clinical investigations, regulatory, reimbursement og post market clinical follow up.

• 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.

FDA Regulation of Medical Devices

Det er vigtigt at forstå love, regler, processer og retningslinjer for medicinsk udstyr for at kunne få medicinsk udstyr på det amerikanske marked.

IEC 60601 - Applying safety and risk management to electrical medical equipment and systems

Hvordan man anvender safety and risk management to electrical medical equipment og systemer.

Industrial Sterilization of Medical Devices - An Introduction to the Practical Approach of Sterilization

Hovedformålet med kurset er at gøre deltagerne i stand til at træffe et kvalificeret indledende valg af den mest egnede steriliseringsmetode til deres pågældende medicinske udstyr.

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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 the EU Medical Device Regulation (MDR 2017/745)

This 1 day introductory course provides a practical and accessible overview of the MDR—ideal for professionals who need a solid foundation without diving into technical complexity. Participants will gain clarity on regulatory expectations, roles and responsibilities, and the steps required for conformity.

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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.

• Other sectors

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.

MDR Auditing – Training of internal auditors in relation to MDR

Få viden om de MDR-krav, der ikke er omfattet af ISO 13485, og forstå MDR-kravene i relation til QMS og deres indvirkning. Lær, hvad du skal være opmærksom på, når du auditerer et QMS i forhold til MDR-kravene.