ISO 13485, cGMP, FDA, CE compliances

The legal landscape for Medical Device industry is very dynamic in nature. To successfully traverse this landscape requires strong intellectual property and a pathway through the regulatory terrain. We have tie-ups in collaboration with whom we offer Consultancy services for Quality Systems implementation and ensure ISO 13485, FDA and other Regulatory Compliance as “Compliance makes good Business sense”

We combine optimized efforts and resources to achieve a faster time-to-market for medical devices.

The pain areas of regulatory compliance for Medical Device manufacturers are:

  • Lack of expertise in obtaining regulatory approvals
  • Process improvement and effective utilization of resources to sustain market competitiveness
  • Intellectual Property Rights (IPR) Management
  • Implementing GxP systems by effective change management
  • Customer Relationship Management (CRM)
  • Rapid data recovery
  • Compliance to international regulatory norms
  • Integrating diverse data transacted across the business process

We will work with your team to full regulatory clearance.