Quality Management solutions for Medical Devices

Companies that produce and sell Medical Devices require strict regulatory compliance and rigorous controls to guarantee product safety and precision in performance. A proper QMS setup allows Quality and control departments to operate with excellence, managing protocols, procedures, and all technical checks that need to be performed to identify deviations before products are released to the market.

We understand what is critical for our clients in the Medical Devices business

The Quality assurance processes and controls for Medical Devices are highly regulated by the FDA, EMA, and other regulatory entities that establish protocols to ensure the safety, efficacy, and performance of products to protect patients' lives.

Compliance & documentation

Being ready to act fast on risk prevention or mitigation with fast access to documents, procedures, and a clear picture of where products are distributed, in case of a recall, for example.

Traceability & Risk Management

Operating within ISO 13485 standards ensures that companies have the best-in-class controls for medical device production and distribution. Having a QMS structure to support complex Quality control and audit processes helps companies improve the effectiveness of HACCP to ensure product safety.

Strict Control

Our EQMS is used by companies that are global references in the Medical Devices industry

Icologiq's specialized team supports each client to configure our standard solutions for their specific use cases, business structure, and locations, which allows our consultants to have relevant knowledge on industry-specific insights at global level.

These are some examples of what can be supported by Icologiq Elements in Medical Devices Quality Management:

Setting up and controlling the consistency of parameters and procedures at the global level for multiple locations.
Tracking compliance with regulatory requirements and international standards and implementing structured audit plans.
Mapping and preparing risk assessments to prevent or mitigate crises.
Fast and easy access to Quality test results and documentation.
Setting up and tracking product effectiveness parameters.
Monitoring customer satisfaction with product performance and having a structured flow for complaints.