Software Consulting

Software Consulting

Quality Management Systems

MedTech QMS - specialized consulting, implementation, and maintenance solutions to medical device manufacturers comply with regulatory standards (ISO 13485, FDA 21 CFR 820, EU MDR, EU IVDR, Indian MDR).

QMS Services

  • QMS design and implementation- Process definition, procedures, templates. Document Management, etc..

  • Digitalization and AI-enabled processes and guidance for AI process framework and product development

  • Gap assessment and continuous improvement

  • Support for Regulatory Compliance, Audits, and ISO 9001 and 13485 Certifications

  • Measurements, performance monitoring, and continuous improvement

  • Framework for Supplier quality management and QMS digitalization

Relevant Standards and Regulations

  • ISO 13485 – Medical Devices Quality Management Systems

  • ISO 9001 – Quality Management Systems

  • ISO 42001 - AI QMS

  • IEC 62304 – Medical Device Software Lifecycle Processes

  • ISO 14971 – Risk Management for Medical Devices

  • ISO 62366-1 – Usability Engineering

  • FDA 21 CFR Part 820 (QSR)

  • EU MDR (2017/745) & IVDR (2017/746)

  • EU AI act and EU Data act