Developing a medical device or health technology software requires more than product development. It also takes regulatory expertise, a functioning quality system, systematic risk management and clinical evidence. Health technology consulting brings these areas of expertise in when they are not available in the organization or there is no time to build them. Well-timed expert support speeds up time to market and reduces costly rounds of rework.
What does health technology consulting involve in practice?
The content of consulting depends on the type of product and its stage of development. Support typically focuses on the following areas:
- product classification and defining the regulatory pathway (MDR, IVDR, software as a medical device)
- building a quality system in accordance with ISO 13485
- risk management (ISO 14971) and software lifecycle processes (IEC 62304)
- usability engineering (IEC 62366-1)
- technical documentation and clinical evaluation
- preparing for a notified body audit
An expert can act as a sparring partner, carry out an individual analysis or take responsibility for preparing an entire area.
When should you seek medical device consulting?
The best time is as early as possible, before design decisions are locked in. Typical situations include:
- the product is still at the concept stage and it is unclear whether it is a medical device
- the organization comes under the requirements of the MDR or IVDR, for example because of a new product or a product change
- a quality system does not yet exist or does not cover software development
- a notified body audit is approaching or a previous audit has resulted in nonconformities
- in-house resources are not sufficient for producing documentation alongside product development
Why should regulation be taken into account at the start of product development?
Regulatory requirements directly affect how a product is designed, tested and documented. If the requirements are noticed only once the product is finished, work often has to be done retroactively that would naturally have been part of the development process. For example, records of risk management, traceability and usability engineering are much easier to produce during development than to reconstruct afterwards.
Early support also helps with realistic scheduling. The time required for clinical evaluation, technical documentation and notified body assessment often surprises a company bringing its first device to market.
Why is health technology consulting worthwhile?
Health technology consulting is an investment that pays for itself through faster progress, less rework and greater certainty of meeting regulatory requirements. Compliance is not a one-time achievement but remains part of the product throughout its lifecycle. For this reason, a partner should be chosen with a long-term view.
Clinipower supports health technology companies in matters of quality and regulation, usability, product development and business. Tell us about your situation, and we will work out together what kind of support would serve you best.
