Health Tech
Software products in highly regulated environments, such as healthcare, require a special approach. I have deep knowledge and experience in building software for the health tech industry, the problems to get around and common pitfalls.
Software as a Medical Device
When building software as a medical device all the usual challenges of software product development are amplified. The software needs to be reliable, secure, and compliant with regulations. At the same time, the product needs to be delivered fast and in a way that is approachable for the development team.
I have experience in building software as a medical device leveraging agile methodologies that allow for fast delivery and quick release cycles. I have worked with various technologies and platforms, such as mobile apps, web apps, and cloud services.
You need expertise with
- Building software as a medical device,
- Agile development in a regulated environment (e.g. ISO 13485, FDA, etc.) or
- Speed up release cycles?
ISO 13485 - QMS
Combining compliance with regulations and agile development has been a challenge in all environments I have worked in. I have gained significant experience in creating lean processes that are compliant with ISO 13485 and get delivery teams to buy into them.
If you need support with
- Bringing true agility into your processes,
- Define processes such as Software Development, Data Integrity, Risk Management, etc. and keep them lean,
- De-clutter your processes and make them more approachable or
- Unblock delivery by identifying and removing process bottlenecks
Data Security
When working with patient healh information (PHI) and other personal identifiable information (PII), a huge variety of regulations and laws apply. I have experience in working with GDPR, HIPAA, and how to accomplish anonymization of data.
If need additional expertise in
- Compliance with GDPR, HIPAA, etc.,
- Education and training of your teams in data security or
- Anonymization of data