Medical Device Engineering
From product definition
Medical device startups and innovators, we`re with you every step of the way.
Your optimal development path starts with careful planning. We plan your medical device development and certification pathway carefully and in detail; with exact deliverables, milestones, and budgets.
Development & Engineering
We design, engineer, verify, and validate your medical device. Quality assurance, safety, risk mitigation, and diligent compliance documentation will underscore your development path end to end.
We work with you to review and finalize compliance documentation. We prepare post-market surveillance documentation and procedures, and support you during clinical evaluations.
Do you need help getting your medical device to the next milestone?
We're here for you!
Engineering in line
with medical device regulations
When developing a medical device, safety comes first.
Quality management system
ISO 13485, ISO 9001
Standards for medical device development
IEC 60601 family, ISO 14971, IEC 62304, IEC 62366
We are with you every step of the way.