Medical Devices

The Medical Device industry is battling with many challenges and undergoing transformational changes due to reduced R & D budgets, pricing pressures, intense competition, ability to address and meet the demands of new growth markets, regulatory controls, etc. and device development strategies needed to take advantage of technologies like big data, cloud, analytics and mobility to address opportunities arising out of changed customer demands and emerging markets.

MontBleu Technologies medical devices service offerings focus on four core areas for medical device manufacturers;

Research-Innovate

  • Benchmarking and Competitor analysis
  • Co-creation workshops
  • Visualization and Mock ups
  • Cognitive walk through
  • Field trials
  • Functional Analysis
  • Formative usability studies

Design–Develop

  • Product Conceptualization focusing on product definition, requirement specifications, system architecture.
  • Product development focusing on industrial design, software and hardware design, wireless technology integration, design for compliance, design for manufacturing, design for product value.

Verify–Validate

  • Highly mature quality processes that are complaint with ISO 13485, ISO 27001, IEC 60601, IEC 62304 and deep understanding of regulatory frameworks like FDA, UL, CE, RoHS help in securing faster approvals and reaching markets on time, every time.
  • DHF remediation and adhering to UDI requirements to meet the quality and documentation needs for FDA certification

Realize

To ensure a seamless transition between design development and full production

MANUFACTURING PROCESS VALIDATION

Manufacturing process validation of medical devices is an essential and challenging part of medical device engineering and global corporations must meet the multiple regulations like FDA and ISO 13485 for all of their manufacturing facilities. Non-compliance with these requirements may lead to FDA non-conformities. We can help you to validate the medical device manufacturing process meeting ISO 13485 requirements.

  • Requirements identification for validation
  • Validation protocols, tools and techniques
  • Monitoring and control
  • Validation Gap analysis
  • Revalidation & Conformance

QUALITY CONSULTING

Medical device manufacturers who want to supply their products in emerging geographies are subjected to a variety of quality system regulations with their own unique set of requirements.

MontBleu will help you prepare appropriate documents and assist in getting safety certifications to bring your new products into compliance with the requirements of the FDA Quality System Regulation (FDA QSR) and ISO 13485. In addition, we will provide training, assistance in implementation, and a final audit in preparation for all your required inspections.

  • Implementation of Quality Management System (FDA QSR / ISO 13485)
  • Gap Analysis with regard to Quality Management System
  • Post marketing surveillance activities like CAPA, post market risk management, complaint management, failure analysis, etc
  • Risk Management consulting as per ISO 14971:2007
  • Audits and assessment services
  • Safety certifications through agencies like TUV, UL, CSA