ISO 14971 Training Courses on Medical Device Risk Management

Comply Guru are the first in the world to offer Multi-Accredited ISO 14971 Risk Management Training with the Chartered Quality Institute (CQI), International Registrar of Certificated Auditors (IRCA) and the Regulatory Affairs Professionals Society (RAPS) offering credentials for the Medical Device Industry that are globally recognized.

ISO 14971 specifies terminology, principles, and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. This international standard would be considered best practice and a benchmark for the Medical Device Industry.

Comply Guru offer different types of ISO 14971 training courses depending on the target audience and training needs. We can also tailor training to meet your company’s specific needs or requirements. Our courses are available in multiple formats from eLearning, Blended Learning or Instructor-led Learning to help you or your organization master Medical Device Risk Management.

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Advanced Risk Practitioner (ISO 14971) for Medical Devices
4.5 ★★★★★ 14 Reviews
ISO 14971 Medical Devices

Advanced Risk Practitioner (ISO 14971) Training

18hrs
RAPS Certified Course
Price: £895.00

Advanced Risk Practitioner Training provides a comprehensive overview of ISO 14971 and workshops with an experienced Practitioner to help you transform the knowledge to practical skills you can immediately apply back at your place of work.

ISO 14971 Requirements for Practitioners and Auditors
4.4 ★★★★★ 474 Reviews
ISO 14971 Medical Devices

ISO 14971 Requirements Training

10hrs
CQI-IRCA Certified Course RAPS Certified Course
Price: £495.00

ISO 14971 Training for Practitioners and Auditors provides a comprehensive overview of the international standard for risk management for medical devices, ISO 14971.

Introduction to ISO 14971 Training
4.3 ★★★★★ 10 Reviews
ISO 14971 Medical Devices

Introduction to ISO 14971

45mins

Introduction to ISO 14971 Training is for organizations looking for a short, high-level introduction for their staff.

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Design Controls, Design and Development under FDA QMSR
Design Controls, Design and Development under FDA QMSR
Michelle discusses Design Controls, ISO 13485 Design and Development and what endures under the FDA's QMSR in effect from February 2026....
Reaffirmed, Not Static: ISO 13485 and the Global Regulatory Evolution
Reaffirmed, Not Static: ISO 13485 and the Global Regulatory Evolution
Michelle discusses the recent affirmation of ISO 13485:2016 and shares her insights on the new guidance reflecting a Global Regulatory Evolution....
Low Risk Does Not Mean No Risk
Low Risk Does Not Mean No Risk
Michelle discusses why ISO 13485 and ISO 14971 make a critical clarification on Risk, and clarifies a dangerous misconception in medical device develo...

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