Do not be fooled – Design and Development is more than just a Design History File!

Real engineering and manufacturing knowledge, specifically in the medical technology space, is what is needed, and it is what our team possesses.

Specially for MedTech Start-Ups and Companies Diversifying into MedTech




We provide in-depth, unerring consulting in design planning, design input, design output, design transfer, organisation design reviews, integrating risk management processes and validation / verification

Here is how we can help you:

– Garbage-in, garbage-out – we work with you to explain what exactly is design input

– Systematically help you collate all inter-disciplinary inputs to the design input for your product.

– The end result is clear, structured, and provide a solid foundation for your downstream design.

– Identify relevant standards & regulatory requirements

– WHEN and HOW to apply them exactly

– Integrating risk management elements to the engineering and product development according to ISO14971 – something very few can do very well. Because we wrote the standard.

– Establish the risk management file together

– CORRECT way of conducting the risk analysis (because we contributed to writing the standard)

– Establish the risk management feedback loop with your design, and go further by ensuring the risk controls translates to the necessary design changes.

– Medical Device Usability gap analysis

– Provide design recommendation to achieve compliance in IEC62366, Human Factors Engineering

– Review the content, level of detail, and correctness of the design documents to ensure it fulfills all applicable regulatory requirements (ISO13485, FDA CFR Part 21 Section 820) and the quality of its contents for a safer, better product.

– Line-for-Line Documentation Reviews

– Act as independent for design review

– Technical File establishment together with the design team

– With the knowledge from the upstream process, we provide consultation and mentorship to adapt your product design and its related risk mitigation plans for the process and for manufacturing.

– Develop strategic sourcing plan with the company, for budgeting and supplier controls

– Develop production specifications for your control plan

– Design of production line/processes to manufacture, assemble and test

– Define your process validation planning, gage R&R, validation protocols and maintenance, statistical process control planning.

– Initial small-volume manufacturing to scale-up

Gain more ideas by checking out our case study.

For a tailor-made mentorship program, it always helps to have someone to talk to.