Develop medical device software centred on patients and compliant with ISO 13485, IEC 62304 and MDR

Take advantage of our ready-to-use quality management system:
● designed for seamless ISO 13485 and GMP/FDA audits,
● with a full set of standard operating procedures for your medical device development and submission needs,
● including workflows to ensure compliance with the latest medical regulations at all phases of your device lifecycle.

Get trained in ISO 13485, ISO 14971 Medical Device Risk Management, IEC 62304 Medical Device Software life cycle processes, Verification and Validation of Medical Devices.

Implement, adapt or improve the QMS ISO 13485 and a certification process in your organisation with support from our specialists.

Make your product development process successful right from the start:

● conceptualise your product or product vision through workshops with our experts,
● get support with establishing Regulatory Strategy, Medical Device classification and Software classification documents,
● ensure your Medical Device Risk management is performed according to ISO 14971 Medical Device Risk Management,
● have software architects draw initial solution architecture,
● get assistance in planning and tailoring Medical Device Software life cycle processes according to IEC 62304 and your needs,
● implement a Proof of Concept, that will allow you to quickly check your business constraints or any technological aspects,
● have a Clinical Trial performed on your ready-to-use solution.

Have your product designed and developed according to Agile Development Lifecycle and in compliance with IEC 62304.

● Strategy:regulatory requirements, POC, initial architecture
● Pre-development: intended use definition, medical device & software classification, compliance strategy
● Quality management: support and/or creation of quality management system in line with ISO 13485
● R&D process: effective process adaptation and adjustment
● Clinical trial: support and solution delivery
● Software risk assessment: compliance check with ISO 14971

Ensure your submission or certification process goes without a hitch.

We’ll support you in:
● reviewing your submission/certification documentation including the Technical File,
● creating Submission Readiness Report with highlighted GAPs,
● resolving issues found,
● preparing submission or certification documentation, CE Marking, 510K.

Meet EU MDR requirements with our help in:
● medical device re-classification,
● Technical File adjustment and preparation,
● identifying and resolving any obstacles in the submission process.

Your solution will be:
● monitored in real time,
● auto-scalable because it’s based on the cloud/AI,
● designed with high usability guaranteed by ISO 62366 compliance,
● safe by design and compliant with IEC 62304 and ISO 27001.

You can also have us handle the post-market activities, such as:
● product maintenance,
● L1 – L3 support lines,
● data collection and analysis,
● post-market Activities Management System and reporting,
● constant improvements and adaptation to changing requirements.