ISO 13485 Training – Quality Management Systems for Medical Devices

Description

ISO 13485 Training on QMS requirements: Medical Device Industry Education (GMP Training Materials).

Course Description

This ISO 13485 online compliance training course provides a comprehensive understanding of ISO 13485 requirements. It is designed for Quality Managers, Regulatory Authorities, Auditors, and operations personnel involved in medical device manufacturing and distribution.

Recommended follow-up training: ISO 14971 (Quality Risk Management Requirements).

What is ISO 13485?

ISO 13485 is a globally accepted standard outlining QMS requirements for medical device companies. It is referenced by Regulatory Authorities worldwide during site inspections and audits of medical device manufacturing and distribution processes. It is also used by Auditing Organizations (AOs) participating in the IMDRF MDSAP program (Medical Device Single Audit Program).

The FDA has recently updated its 21 CFR Part 820 to align with ISO 13485 standards. This change takes effect on 2 February 2026.

Compliance with ISO 13485 requirements is essential for medical device personnel, including:

• Manufacturing personnel
• Subcontractors
• Material suppliers, facility contractors, and equipment maintenance teams

Course Overview: Key Topics Covered

This ISO 13485 compliance training course by PharmOut covers essential QMS requirements, including:

• Overview of the medical device industry and regulatory landscape
• QMS requirements and regulatory authority expectations
• Establishing quality objectives and maintaining a quality manual
• Risk management responsibilities
• Outsourcing and supplier management
• QMS recordkeeping and documentation
• Personnel competency assessments and training programs
• Management product reviews and safety monitoring
• Risk management strategies and assessment techniques
• ISO 13485 vs. MDSAP: A comparison
• Common audit findings related to medical device QMS deficiencies

FAQs Answered in This Course

• What are the regulatory requirements for an effective QMS?
• What documentation controls are needed for ISO 13485 compliance?
• What personnel training is required for medical device quality assurance?
• How do self-inspections, audits, and management reviews ensure quality control?
• How does ISO 13485 compare to MDSAP and ISO 9001?
• How does ISO 14971 relate to QMS requirements?

Who Should Take This Training?

This course is ideal for individuals involved in medical device manufacturing, compliance, and auditing, including:

• Medical device company founders/CEOs
• Product developers, engineers, and testing personnel
• Quality Managers and Quality Associates
• Contractors, subcontractors, and material suppliers
• Medical device service providers, validation teams, and purchasing teams
• QMS documentation specialists

It is also suitable for manufacturers, personnel, suppliers, contractors and Regulatory Authorities participating in MDSAP.

You should follow up this course with ISO 14971 (Medical Device Risk Management training materials)

ISO 13485 Training by PharmOut

• This training is designed to help individuals understand ISO 13485 requirements for medical device compliance.
• Learners should purchase the ISO 13485 standard publication from ISO.org for reference during and after the course.

Global Audience & Regulatory Examples

This training is designed for a worldwide audience and includes regional regulatory references, such as:

• FDA (U.S.) – 21 CFR Part 820
• TGA (Australia) – Medical device compliance guidance
• MHRA (UK) – QMS requirements
• EMA (European Union) – ISO 13485 compliance
• ASEAN & other global regulators

How to Use Your Licenced ISO 13485 publication with This Course

• This course highlights key QMS responsibilities and documentation requirements per the ISO 13485 standard for medical device manufacturers.
• After buying your ISO publication directly from the International Organization for Standardisation,:
  • Reviewing your licenced copy of the ISO 13485 standard before and after this training course.
  • This will enhance your understanding and retention of compliance expectations.
  • You can repeat these learning materials as often as you’d like for 12 months’ from date of purchase.

Certification & Compliance

Upon successful completion of the final assessment, participants will receive a Certificate of Completion, which meets GMP training requirements for personnel files and regulatory audits.

How to Enroll

1. Purchase the course online and receive immediate access.
2. All prices are in US Dollars.
3. Check your email for login details after completing your order (search all folders for ‘onlinegmptraining.com’ or ‘pharmout.net’ and add these to your safe senders list).
4. You can purchase a single course or just a few of the courses you need for just-in-time learning.
5. Note: one learner, one licence
6. The learner will have 12 months’ access to the course and a downloadable GMP certificate of completion.
7. Optional: Bundle this training with other GMP courses for additional learning.

Start Your Training Today!

Ensure compliance with ISO 13485 and improve your medical device QMS knowledge.  One cGMP course Certificate of Completion per each course completed.

Enroll now and gain your ISO 13485 Training Certificate to support regulatory and industry requirements.

Start your online GMP training today! Be sure to read the FAQs so you know what to expect.

Click here for additional GMP Training Materials & GMP education topics. 

• ISO 13485:2016 compliance training (Medical Device QMS Guidelines/Medical Device Regulations) is ideal to complete along with the Complaints Management course, the Deviations and Non-Conformances management course, and the CAPA systems training course.
• Subsequent to completing ISO 13485, learners should complete the ISO 14971 – Medical Device Risk Management training course.

GMP industry and Medical Device Regulatory Compliance Training experts

• This is one of our many GMP education topics eLearning courses available 24/7.
• Click here for online courses specific to the Medical Device industry.
• Click here for a list of face-to-face courses delivered via Zoom (onsite training of large groups of personnel may also be available, where feasible).

With online training for ISO13485, product recalls, CAPA implementation and other GMP education topics, you can mix and match GMP education courses with a training bundle package.

Note: All course prices are in US dollars.

Resources

Review other top-ranked GMP courses and best-practice GMP training courses.

• Click here for Deviation Management examples and templates.
• Technical writers for SOPs are also available as PQS/QMS consultants/writers.