Medical devices engineering services

Collecting product requirements from the scratch, we design, manufacture and test full functional medical hardware for:
- class I, IIa and IIb,
- Class III devices.
- Medical Devices IVD

Electrical schematics and PCB routing for prototypes or pre-series to complex systems including distributed control based on major industrial/medtech communication buses.

Simulations and best design practices allow our designs full compliance with IEC standards for EMC and electrical safety requirements.

Medical class software development

Class A, B or C software and firmware development following latest development and testing methodologies

ISO 60601 and ISO 13485 standards for medical devices design and manufacturing

IEC 60601, standard iso 13485 compliance electrical and electronics designs are part of the day to day medical devices used by doctors in major hospitals worldwide.

Safety first electronical developments using latest technologies for class I, II and III medical devices.

Medicine advanced data management systems

Medical devices connectivity

Medical device mechanical design

Medical device manufacturing

Medical device design transference to mass production by the hands of experience manufacturing engineers, providing supply chain forecast and manufacturing risk assessment.

Meddev Quality Assurance documentation production

EU Medical Device Regulation ISO 13485 (Quality Management Systems) ISO 14971 (Risk Management) IEC 62304 (Software Life Cycle Processes) IEC 82304 (Health Software) IEC 62366 (Usability Engineering)

Medical device manufacturing processes automation

Take advantage of Medops manufacturing expertice by triying out our Medical Device focused ERP while our team analyzes your manufacturing and supply chain requirements:

Mass production optimization
Prototyping assessment
Raw material import
Medical device export
Logistics
Worlwide Med Suppliers