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Postgraduate Diploma in ISO 13485, QMS and Validation

Online Postgraduate Diploma of 800 h in ISO 13485, QMS and Validation. 8 modules covering ISO 13485:2016, Regulation (EU) 2017/745 and Greenlight Guru. Assigned tutor and open enrolment.

Duration800 h
ModeOnline
AwardSEIUM Institute diploma
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Learning outcomes

What you will be able to do

01

Implement a quality management system compliant with ISO 13485.

02

Apply design controls and traceability.

03

Control the production processes of medical devices.

04

Validate special processes using IQ, OQ and PQ protocols.

05

Validate the quality system software using a risk-based approach.

06

Manage CAPA, complaints and surveillance.

07

Prepare for audits by notified bodies and the FDA.

Profile

Who it's for

  • Quality manager looking to specialise in ISO 13485, QMS and Validation.
  • Validation engineer looking to specialise in ISO 13485, QMS and Validation.
  • ISO 13485 internal auditor looking to specialise in ISO 13485, QMS and Validation.
  • Regulatory affairs specialist looking to specialise in ISO 13485, QMS and Validation.
  • Manufacturing process engineer looking to specialise in ISO 13485, QMS and Validation.
  • CAPA technician looking to specialise in ISO 13485, QMS and Validation.
  • Graduates in engineering or science seeking to enter the medical device sector.
Standards & tools

What you'll work with

  • ISO 13485:2016
  • Reglamento (UE) 2017/745
  • 21 CFR Part 820
  • ISO 14971
  • 21 CFR Part 11
  • ISO/TR 80002-2
  • ISO 11607-1
  • ISO 14644-1
Syllabus

8 modules · 800 h

  1. 1.1Structure and scope of ISO 13485:2016
  2. 1.2Differences from ISO 9001
  3. 1.3Integrated regulatory requirements
  4. 1.4Risk-based approach
  5. 1.5Quality manual and documentation
  6. 1.6Document and record control
  7. 1.7Management responsibility
  8. 1.8Resource management and competence
  9. 1.9Infrastructure and work environment
  10. 1.10Case study: process map of a manufacturer
  1. 2.1Design and development planning
  2. 2.2Design inputs and outputs
  3. 2.3Design reviews
  4. 2.4Design verification and validation
  5. 2.5Transfer to production
  6. 2.6Design change control
  7. 2.7Design History File (DHF)
  8. 2.8Integration of usability and risk
  9. 2.9FDA design control requirements
  10. 2.10Workshop: design traceability matrix
  1. 3.1Production planning
  2. 3.2Device Master Record (DMR) and Device History Record (DHR)
  3. 3.3Cleaning and contamination control
  4. 3.4Identification and traceability
  5. 3.5Supplier control and purchasing
  6. 3.6Measuring equipment and calibration
  7. 3.7Nonconforming product
  8. 3.8Sterilisation and packaging
  9. 3.9ISO 14644 cleanroom requirements
  10. 3.10Practice: process control plan
  1. 4.1Special processes and their validation
  2. 4.2IQ, OQ and PQ protocols
  3. 4.3Statistics for validation
  4. 4.4Justified sample sizes
  5. 4.5Validation of sterilisation processes
  6. 4.6Packaging seal validation to ISO 11607
  7. 4.7Revalidation and change control
  8. 4.8Validation documentation
  9. 4.9GHTF guidance on process validation
  10. 4.10Laboratory: capability analysis in Minitab
  1. 5.1Software in the quality system
  2. 5.2ISO/TR 80002-2 and its approach
  3. 5.3GAMP 5 risk-based approach
  4. 5.4Validation of computerised systems
  5. 5.521 CFR Part 11 and electronic signatures
  6. 5.6Data integrity ALCOA+
  7. 5.7Validation of spreadsheets
  8. 5.8Software as a service and suppliers
  9. 5.9Computer software assurance
  10. 5.10Case study: validation of an eQMS
  1. 6.1Feedback and complaints
  2. 6.2Surveillance and incident reporting
  3. 6.3Internal audits
  4. 6.4Corrective and preventive actions (CAPA)
  5. 6.5Root cause analysis
  6. 6.6Data analysis and trends
  7. 6.7Management review
  8. 6.8Post-market follow-up
  9. 6.9Recall management
  10. 6.10Practice: complete CAPA investigation
  1. 7.1Notified body audits
  2. 7.2MDSAP programme
  3. 7.3FDA Quality Management System Regulation (QMSR)
  4. 7.4FDA inspections and Form 483
  5. 7.5Unannounced audits
  6. 7.6Supplier audits
  7. 7.7Staff preparation for audits
  8. 7.8Responding to findings
  9. 7.9Maintaining certification
  10. 7.10Case study: response to a major nonconformity
  1. 8.1System organisation and scope
  2. 8.2Gap analysis against ISO 13485
  3. 8.3Documented key processes
  4. 8.4Design control plan
  5. 8.5Process validation protocol
  6. 8.6Software validation plan
  7. 8.7Audit programme
  8. 8.8Certification roadmap
  9. 8.9Report and presentation
  10. 8.10Final review with the tutor
Methodology, software & labs

How you'll learn

100% online training on the SEIUM campus, with downloadable material, recorded classes and assigned technical tutor. No fixed timetable: students progress at their own pace within the enrolment period, making it possible to combine with work.

Each module combines theory, guided reading of the original standard and applied exercises. The working software is Greenlight Guru, MasterControl, Veeva Vault QMS, Minitab, in free, academic or evaluation versions. Tests are studied using real IQ/OQ/PQ process validation procedures, internal QMS audit and validation of a computerised system. Assessment is continuous per module plus the final integrative project.

Accredited laboratories(EN ISO/IEC 17025) with a rotor test rig, EMC/Lightning pre-compliance, HIL/SIL, vibration/acoustics.
Evidence-driven final project:safety case, test plan, compliance dossier and operating limits.
Industry mentoring:lecturers with experience in training, , eVTOL/UAM and flight test.
Flexible format(hybrid/online), international cohorts and support from SEIUM Career Services.
Ethics and safety:a safety-by-design approach, cyber-OT, DIH and compliance as its pillars.
Capstone project

Build it end to end

Your final project follows the real engineering workflow, step by step, reviewed by your tutor.

System organisation and scope

Implement a quality management system compliant with ISO 13485.

Gap analysis against ISO 13485

Apply design controls and traceability.

Documented key processes

Control the production processes of medical devices.

Design control plan

Validate special processes using IQ, OQ and PQ protocols.

Process validation protocol

Validate the quality system software using a risk-based approach.

Career opportunities

Where this takes you

Quality managerValidation engineerISO 13485 internal auditorRegulatory affairs specialistManufacturing process engineerCAPA technician
Admissions & scholarships

Requirements

  • Prior technical training or professional experience in the sector. No university degree is required.
  • Internet connection and a computer capable of running the programme's software.
  • Sufficient Spanish to follow technical regulatory reading.

Ready to start?

Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.

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FAQ

Frequently asked questions

The programme is 800 hours in total, spread over 6 to 8 months. That is between 10 and 15 hours per week on average, compatible with full-time work.

Work is carried out with Greenlight Guru, MasterControl, Veeva Vault QMS, Minitab. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.

An SEIUM own diploma upon passing the continuous assessment and the integrative project. It is in-house training, not an official qualification from the Ministry.

Yes. Modules passed in a course or postgraduate diploma in the same area are recognised towards the advanced programme. Check the recognition policy when you enrol.

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