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Postgraduate DiplomaHealth, Biomechanics, Wearables & Operational Safety Applications open

Diploma in Technical Documentation and Technical File Design

Online postgraduate diploma of 800 hours in technical documentation and technical file design. 8 modules covering documentation fundamentals, the regulatory framework, technical file design, writing information for use, structured authoring, PLM integration, documentation review and an integrative case study, with an assigned technical tutor.

Duration800 hours · 6–8 months
ModeOnline
LanguageEnglish
Start datesSet by the faculty
AwardSEIUM Institute diploma
Enrol now View syllabus Ask an advisor

Diploma in Technical Documentation and Technical File Design — studying from India

India's medical device and healthcare technology sector is growing, with manufacturing and design clusters in Hyderabad, Bengaluru, Ahmedabad and the National Capital Region. Regulation of medical devices is handled by the Central Drugs Standard Control Organisation under the Central Drugs Standards Control Organisation framework, and the Bureau of Indian Standards issues relevant norms. Hospitals, device makers and rehabilitation technology firms create demand for biomechanics and wearables expertise. Operational safety and occupational health are overseen through the Directorate General Factory Advice Service and Labour Institutes, making this area relevant to industrial and healthcare engineers alike.

Fees for India: ₹95,000 (Indian Rupee), with instalments and employer sponsorship available.

Relevant bodies in India

  • Central Drugs Standard Control Organisation (CDSCO)
  • Bureau of Indian Standards (BIS)
  • Indian Council of Medical Research (ICMR)
  • Directorate General Factory Advice Service and Labour Institutes (DGFASLI)

Typical roles

  • Biomedical Engineer
  • Medical Device Engineer
  • Wearables Development Engineer
  • Occupational Safety Engineer

Questions from India

Will this programme be recognised by professional bodies in India for health and biomechanics work?

SEIUM's qualifications are private qualifications, not official state degrees, and they are not accredited by any national body in India. Recognition is decided by employers and by the relevant body in each case. Medical devices fall under CDSCO, and professional engineering recognition in India is handled by bodies such as the Institution of Engineers (India). Please check with them directly before relying on the qualification.

Which employers in India use skills in biomechanics, wearables and operational safety?

Typical employers include medical device companies, hospitals with engineering departments, sports science organisations, and firms making wearable or industrial safety products. Hiring depends on the employer's own criteria and on your existing experience. The qualification may help you show specialist knowledge, but whether a particular employer values it is for that employer to decide.

Can I study this alongside a full-time job in India, and does it need English?

The programme is 100% online and taught in English, so you need a working level of English. Time zone is not a barrier because the course is asynchronous, and you can study from anywhere in India without a student visa. Workload depends on the programme length, and each student is assigned a technical tutor for support. Many people fund it through employer sponsorship or pay in instalments.

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Learning outcomes

What you will be able to do

01

Understand the purposes, audiences and legal role of technical documentation.

02

Apply IEC/IEEE 82079-1, ISO 20607 and NLF requirements to real products.

03

Structure technical files that support conformity assessment.

04

Write clear, safety-oriented instructions with Simplified Technical English.

05

Build reusable structured content with DITA and Oxygen XML Editor.

06

Integrate documentation with engineering change and PLM processes.

07

Lead the documentation and technical file strategy of a product range.

Profile

Who it's for

  • Technical writers and documentation specialists.
  • Compliance engineers who prepare technical files.
  • R&D engineers responsible for product documentation.
  • Regulatory affairs professionals in industrial and medical technology.
  • Documentation and content managers.
  • Product managers in manufacturing companies.
  • Engineering or communication graduates seeking to specialise in technical documentation.
Standards & tools

What you'll work with

  • IEC/IEEE 82079-1 (preparation of information for use)
  • ISO 20607 (instruction handbook for machinery)
  • ISO 7010 (safety signs)
  • ISO 3864-2 (product safety labels)
  • Decision 768/2008/EC (New Legislative Framework)
  • Machinery Regulation (EU) 2023/1230
  • Medical Device Regulation (EU) 2017/745 (Annexes II and III)
  • ASD-STE100 (Simplified Technical English)
  • OASIS DITA 1.3
  • IEC 81346 (reference designation)
  • ISO 17100 (translation services)
  • Oxygen XML Editor
  • MadCap Flare
  • Adobe FrameMaker
  • Confluence
Syllabus

8 modules

  1. 1.1Internal documentation (technical file) and information for use
  2. 1.2Purposes: compliance, safety and usability
  3. 1.3The documentation life cycle
  4. 1.4Audiences and user personas
  5. 1.5Information architecture
  6. 1.6Minimalism and task orientation
  7. 1.7Legal role of documentation and liability
  8. 1.8Technical documentation terminology
  9. 1.9Common documentation deficiencies
  10. 1.10Exercise: documentation audit
  1. 2.1Technical documentation in Decision 768/2008/EC
  2. 2.2Machinery Regulation (EU) 2023/1230: technical documentation and instructions
  3. 2.3Low Voltage and EMC Directives
  4. 2.4Medical Device Regulation: Annexes II and III
  5. 2.5Radio Equipment Directive
  6. 2.6Instructions in digital format
  7. 2.7Language requirements
  8. 2.8Retention periods
  9. 2.9Requests from market surveillance authorities
  10. 2.10Exercise: technical file requirements matrix
  1. 3.1Structuring the technical file
  2. 3.2Product description and variants
  3. 3.3Design and manufacturing drawings
  4. 3.4Risk assessment records
  5. 3.5Standards applied and justifications
  6. 3.6Test reports and evidence
  7. 3.7EU declaration of conformity
  8. 3.8Document control and versioning
  9. 3.9Electronic technical files
  10. 3.10Exercise: technical file index
  1. 4.1Principles of IEC/IEEE 82079-1
  2. 4.2Machinery instructions (ISO 20607)
  3. 4.3Safety messages: hazard, consequence and avoidance
  4. 4.4Safety signs and labels (ISO 7010 and ISO 3864-2)
  5. 4.5Simplified Technical English (ASD-STE100)
  6. 4.6Writing procedures and tasks
  7. 4.7Illustrations and graphics
  8. 4.8Accessibility
  9. 4.9Quick guides and online help
  10. 4.10Exercise: instruction chapter
  1. 5.1DITA topic types
  2. 5.2XML authoring in Oxygen XML Editor
  3. 5.3Single-sourcing and reuse
  4. 5.4Variant management
  5. 5.5Component content management systems
  6. 5.6Publishing to PDF and HTML
  7. 5.7Metadata and taxonomy
  8. 5.8Translation management and memories
  9. 5.9Authoring with MadCap Flare
  10. 5.10Exercise: DITA topic set
  1. 6.1Linking documentation to requirements
  2. 6.2Reference designation (IEC 81346)
  3. 6.3Document classification (IEC 61355)
  4. 6.4PLM and ERP integration
  5. 6.5Engineering change management
  6. 6.6Spare parts catalogues
  7. 6.7Digital product passport (Regulation (EU) 2024/1781)
  8. 6.8Working with risk assessment teams
  9. 6.9Documentation planning in projects
  10. 6.10Exercise: documentation change process
  1. 7.1Review workflows
  2. 7.2Usability testing of instructions
  3. 7.3Compliance checks against IEC/IEEE 82079-1
  4. 7.4Translation quality (ISO 17100)
  5. 7.5Documentation metrics
  6. 7.6Assessment by notified bodies and authorities
  7. 7.7Post-market updates
  8. 7.8Archiving
  9. 7.9Continuous improvement
  10. 7.10Exercise: compliance review of instructions
  1. 8.1Definition of the case and success criteria
  2. 8.2Collection of input data and requirements
  3. 8.3Work planning and deliverables
  4. 8.4Technical development guided by the tutor
  5. 8.5Application of the regulatory framework to the case
  6. 8.6Verification of results and critical analysis
  7. 8.7Documentation of the deliverable
  8. 8.8Technical defence and peer review
  9. 8.9Lessons learned and continuous improvement
  10. 8.10Final project: final assessment and programme close-out
Methodology, software & labs

How you'll learn

100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: you progress at your own pace within each intake, so you can combine the programme with your job.

Each module combines theory, guided reading of the original standard and applied exercises. The working software is Oxygen XML Editor, MadCap Flare, Adobe FrameMaker and Confluence, in free, academic or evaluation versions. Practical work is based on real procedures from a technical writing studio, a DITA content management environment and a technical file review workshop. Assessment is continuous by module, plus the final integrative project.

Standards covered: IEC/IEEE 82079-1, ISO 20607, ISO 7010, ISO 3864-2, Decision 768/2008/EC, Machinery Regulation (EU) 2023/1230, Medical Device Regulation (EU) 2017/745, ASD-STE100, OASIS DITA 1.3, IEC 81346, ISO 17100.

Assigned technical tutor:every module ends with a deliverable that your tutor marks individually.
Standards-based learning:guided reading of IEC/IEEE 82079-1, ISO 20607 and ISO 7010 applied to real cases, not as a theoretical annex.
Industry software:Oxygen XML Editor, MadCap Flare, Adobe FrameMaker and Confluence, in free, academic or evaluation versions.
Final project:A complete technical file for a real product, structured for conformity assessment, reviewed by your tutor.
Flexible format:100% online, no fixed timetables, compatible with full-time work.
Capstone project

Build it end to end

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

Documentation audit
Audit the technical file and instructions of a real product.
Technical file index
Design the structure of a technical file for conformity assessment.
Instruction chapter
Write an instruction chapter with safety messages to IEC/IEEE 82079-1.
DITA topic set
Create a reusable DITA topic set with variants and publish it.
Final project
Deliver a complete technical file for a real product, structured for conformity assessment, reviewed by your tutor.
Career opportunities

Where this takes you

Technical writerTechnical file managerDocumentation managerProduct compliance engineerInformation developer (DITA)Regulatory documentation specialist
Admissions & scholarships

Requirements

  • Prior technical training or professional experience in the sector. No university degree is required.
  • An internet connection and a computer able to run the programme software.
  • English sufficient to read technical standards.

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 totals 800 hours over 6–8 months. You set your own pace within each intake, and your tutor helps you plan the workload around your job.

You work with Oxygen XML Editor, MadCap Flare, Adobe FrameMaker and Confluence, using free, academic or evaluation versions. Your tutor indicates the free alternative wherever one exists.

A SEIUM Institute diploma, awarded on passing the continuous assessment and the final project. It is SEIUM's own qualification, not an official state degree; its recognition depends on the programme completed and the regulations of each country.

Yes. Modules passed are recognised in a higher programme in the same area (postgraduate diploma or master's). Ask about the recognition policy when you enrol.

Prior technical training or professional experience in the sector (no university degree is required), plus English sufficient to read technical standards.

Start dates are set by SEIUM's faculty for each intake. Our admissions team will confirm the next available date when you apply.

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