Medical Device Engineering

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.

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

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 line
with medical device regulations

When developing a medical device, safety comes first.

Medical device regulations

EU MDR, USA FDA, China NMPA, Russia RZN & 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