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Regulatory Consulting Services

Regulatory Affairs

We have capabilities to do UDI Implementation, Remediation, Design Dossiers creation, Tech File updates, 510(K) documentation, FDA / EU assessment etc. We have extensive regulatory experience in segments like orthopedic, radiology, laboratory equipments, cardiology and single use devices.

Medical Quality Systems

Medical Devices Quality systems are all about management providing the rigor and discipline to drive product quality to meet customers' needs and providing the information that is the life blood of management effectiveness.

A well-executed quality system drives excellence, bringing your business processes under control and giving you the information you need to drive continuous improvement. Your employees and partners will understand their role in the Quality System and the value they add to it through compliance.

Global Market Reach

When you are selling your products both US and OUS, you will need to meet requirements in multiple markets. You can build one Quality System that is compliant to both ISO 13485 and the US FDA 21CFR 820 Quality System Regulations. We can advise you on more specialist GxP requirements, including ISO14971 and specialist quality systems for clinical laboratories and for R&D facilities or design houses.

Regulatory and Remediation Services

  • DHF, RMF, Translation Services, Documentation
  • CAPA Management
  • Implementation or upgrade of systems to compliance with GMP ISO 13485, FDA 21 CFR 820.
  • Assistance with facility inspections including internal pre-audit and attendance at external audit.
  • Postmarket systems for adverse event reporting
  • Recalls management.
  • Assistance with facility inspections including internal pre-audit and attendance at external audit.
  • Process development and implementation for distributors including
  • Post market systems for adverse event reporting
  • Advertising compliance
  • FDA 483/Warning letter or other Regulatory body non-conformity remediation
  • Recalls management.
  • ISO14971, ISO62304, IEC 60601 3rd Edition.