Postgraduate Diploma in Design for Manufacture and Sterilisation
800-hour online Postgraduate Diploma in Design for Manufacture and Sterilisation. 8 modules covering ISO 11135 (ethylene oxide sterilisation), ISO 11137-1 (radiation sterilisation) and SolidWorks. Dedicated tutor and open enrolment.
Postgraduate Diploma in Design for Manufacture and Sterilisation — studying from the United Kingdom
The United Kingdom has a strong medical technology and healthcare engineering base, with research in biomechanics, medical devices and wearables across universities and companies in London, Oxford, Leeds and Glasgow. The NHS, medical device manufacturers and digital health firms require engineers who understand clinical requirements and regulatory compliance. Operational safety in workplaces, transport and sport drives work on human factors and ergonomics. The Medicines and Healthcare products Regulatory Agency regulates medical devices, and the Health and Safety Executive oversees workplace safety.
Fees for the United Kingdom: £910 (Pound sterling), with instalments and employer sponsorship available.
Relevant bodies in the United Kingdom
Typical roles
Questions from the United Kingdom
Will this qualification be recognised by UK professional bodies such as the Institution of Engineering and Technology or the Institution of Mechanical Engineers?
SEIUM's qualifications are private qualifications, not official state degrees, and they are not accredited by any national body. Professional bodies such as the IET or IMechE decide whether to accept training for membership, usually through their own assessment of your experience and learning. Chartered Engineer status is awarded by the Engineering Council via licensed professional engineering institutions. Check directly with the relevant body before you enrol.
Will UK employers in healthcare technology, wearables or occupational safety value this training on a CV?
Employers decide for themselves how much weight to give a private qualification. Many value evidence of specialist skills, such as a completed final project and demonstrable work on biomechanics or wearable sensor systems, more than the name of the provider. Recognition is not guaranteed, so review relevant job adverts and ask prospective employers how they view online private training before committing.
Can I complete this programme alongside a full-time job in the UK, and does my employer need to fund it?
The programmes are 100% online and taught in English, so you can study at your own pace around work and across UK time zones. Master's programmes total 1,900 hours, postgraduate diplomas 800 hours and specialist courses 300 hours. Fees can be paid in instalments, and employer sponsorship is possible, though you should agree arrangements with your employer in advance.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Apply design-for-manufacture principles to medical devices.
Select manufacturing processes suited to each geometry and material.
Compare sterilisation methods and their validation requirements.
Assess material compatibility with the sterilisation method.
Design sterile barrier packaging systems compliant with ISO 11607.
Define reprocessing instructions for reusable devices.
Establish quality controls for series production.
Who it's for
- Industrialisation engineer wishing to specialise in Design for Manufacture and Sterilisation.
- Sterilisation process engineer wishing to specialise in Design for Manufacture and Sterilisation.
- Medical device quality engineer wishing to specialise in Design for Manufacture and Sterilisation.
- Design for manufacture engineer wishing to specialise in Design for Manufacture and Sterilisation.
- Sterile packaging specialist wishing to specialise in Design for Manufacture and Sterilisation.
- Process validation engineer wishing to specialise in Design for Manufacture and Sterilisation.
- Graduates in engineering or sciences looking to enter healthcare technology.
What you'll work with
- ISO 11135 (ethylene oxide sterilisation)
- ISO 11137-1 (radiation sterilisation)
- ISO 11607-1 (packaging of terminally sterilised products)
- ISO 17665 (moist heat sterilisation)
- ISO 13485 (quality management systems)
- ISO 10993-1 (biological evaluation)
- ISO 17664-1 (information for reprocessing)
- ISO 11607-2 (validation of packaging processes)
8 modules · 800 h
1.1Design for manufacture and assembly principles1.2Reduction of parts and joints1.3Tolerances and dimensional stack-up1.4GD&T according to ISO 11011.5Process selection by volume1.6Target cost and value analysis1.7Design transfer to production1.8ISO 13485 requirements in design1.9DFM review with suppliers1.10Workshop: DFMA analysis of a single-use device
2.1Medical-grade injection moulding2.2Extrusion of tubes and catheters2.3Machining of implants2.4Additive manufacturing in healthcare2.5Ultrasonic, laser and adhesive bonding2.6Cleanrooms ISO 146442.7Moulding in a clean room2.8Laser UDI marking2.9Process validation IQ, OQ and PQ2.10Practice: IQ/OQ/PQ protocol for a weld
3.1Moist heat and autoclaving3.2Ethylene oxide according to ISO 111353.3Gamma radiation and electron beam ISO 111373.4Vaporised hydrogen peroxide3.5Sterility assurance level SAL3.6Bioburden and tests ISO 117373.7Biological and chemical indicators3.8Ethylene oxide residues ISO 10993-73.9Method selection by material3.10Case study: switching from ethylene oxide to electron beam
4.1Effect of radiation on polymers4.2Degradation by heat and humidity4.3Radiation-stable polymers4.4Metals and coatings4.5Adhesives and their sterilisation resistance4.6Accelerated ageing tests ASTM F19804.7Colour changes and embrittlement4.8Extractables and leachables4.9Biocompatibility after sterilisation4.10Laboratory: property testing after irradiation
5.1Sterile barrier systems ISO 116075.2Materials: Tyvek, paper and films5.3Heat sealing and validation5.4Integrity: bubble and dye tests5.5Seal strength ASTM F885.6Transport tests ASTM D41695.7Shelf life and expiry5.8Labelling and symbols5.9Design for aseptic opening5.10Practice: validation of a sealed blister
6.1Cleaning, disinfection and sterilisation6.2Design for effective cleaning6.3ISO 17664 and reprocessing instructions6.4Spaulding classification6.5Cleaning validation6.6Maximum reprocessing cycles6.7Surgical instruments and endoscopes6.8Reprocessing errors and risks6.9Reprocessing of single-use products6.10Case study: redesigning a hard-to-clean instrument
7.1Statistical process control7.2Process capability Cpk7.3Incoming inspection and sampling7.4Change management in production7.5Parametric release7.6Nonconformities and CAPA7.7Supplier audits7.8Device history records7.9Lean continuous improvement7.10Workshop: capability study of a sealing process
8.1Device description8.2DFM analysis8.3Process selection8.4Sterilisation method selection8.5Packaging design8.6Validation plan8.7Quality control plan8.8Cost analysis8.9Report and presentation8.10Final review with the tutor
How you'll learn
100% online training on the SEIUM campus, with downloadable material, recorded classes and a dedicated technical tutor. No fixed timetables: students progress at their own pace within the intake, making it possible to combine study with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is SolidWorks, Autodesk Moldflow, Minitab, Ansys Mechanical, Advanced Excel, in free, academic or evaluation versions. Tests are studied using real validation procedures for sterilisation cycles, sterile packaging integrity tests and process capability studies in a pilot plant. Assessment is continuous per module plus the final integrating project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Apply design-for-manufacture principles to medical devices.
Select manufacturing processes suited to each geometry and material.
Compare sterilisation methods and their validation requirements.
Assess material compatibility with the sterilisation method.
Design sterile barrier packaging systems compliant with ISO 11607.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. A university degree is not required.
- Internet connection and a computer capable of running the programme's software.
- Sufficient command of Spanish to follow technical standards documentation.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme totals 800 hours spread over 6 to 8 months. That is between 10 and 15 hours per week on average, compatible with a full-time job.
You will work with SolidWorks, Autodesk Moldflow, Minitab, Ansys Mechanical, Advanced Excel. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
An SEIUM diploma awarded upon passing the continuous assessment and the integrating project. It is in-house training, not an official Ministry qualification.
Yes. Modules passed in a course or postgraduate diploma in the same area can be credited towards the advanced programme. Please check the credit transfer policy when you enrol.
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