OUR APPROACH
From product definition
to commercialization
Medical device startups and innovators, we're with you every step of the way.
OUR APPROACH
From product definition
to commercialization
Medical device startups and innovators, we`re with you every step of the way.
Develop your medical device at a fixed budget.
Shorten the time to successful certification.
Minimize your overhead while you
remain agile.
Leverage our egineering skills and experience.
Develop your medical device at a fixed budget.
Shorten the time to successful certification.
Minimize your overhead while you remain agile.
Leverage our egineering skills and experience.
01
Product Definition
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.
SERVICES
01
Product Definition
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.
SERVICES
02
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.
SERVICES
02
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.
SERVICES
03
Certification
We work with you to review and finalize compliance documentation. We prepare post-market surveillance documentation and procedures, and support you during clinical evaluations.
SERVICES
03
Certification
We work with you to review and finalize compliance documentation. We prepare post-market surveillance documentation and procedures, and support you during clinical evaluations.
SERVICES
Do you need help getting your medical device to the next milestone?
We're here for you!
REGULATIONS
Engineering in linewith medical device regulations
When developing a medical device, safety comes first.
Medical device regulations
EU MDR, USA FDA, China NMPA & Other countries
Quality management system
ISO 1348, ISO 9001
Standards for medical device development
IEC 60601 family, ISO 14971, IEC 62304, IEC 62366
Medical device regulations
EU MDR, USA FDA, China NMPA & Other countries
Quality management system
ISO 13485, ISO 9001
Standards for medical device development
IEC 60601 family, ISO 14971, IEC 62304, IEC 62366
KNOWLEDGE
Our
know-how
We are with you every step of the way.
