Medical Device Engineering

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.

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.

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.

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.

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.

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.

Do you need help getting your medical device to the next milestone?

We're here for you!


Do you need help getting your medical device to the next milestone?


REGULATIONS

Engineering in compliance
with medical device regulations

We are with you every step of the way.

REGULATIONS

Engineering in line
with 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.

Domains

Radiation Therapy, Medical Imaging, In Vitro Diagnostic, Medical Robotics, Patient Monitoring, Patient Positioning, Motion Control, Image guided automation, Machine vision

Modules

Workflow Manager, Patient Scheduling, Medical Safety System, Treatment Planning, Treatment Control Systems, Oncology Information System, Radiology Information System, Accelerator Control Systems, Dose Delivery System

Skills

Hardware/Electronics, IT Software, Control Systems, Usability Systems, User Interface (UX/IX), Mechanical Design, 3D Printing

Contact information

If you’re looking for some information that you couldn’t find anywhere else on the website, don’t hesitate to contact us.