Regulatory Compliance Services
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. Medical device manufacturers 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
HCL’s Service Offerings:
HCL's Regulatory Excellence Services spans across all the Life Sciences industries (Medical devices, Pharmaceutical Biotech Industries and Healthcare). HCL address the entire value chain of Medical Device companies starting from the Research Development to prototyping and Manufacturing.
Compliance: HCL address the entire value chain of Medical Device companies starting from the Research Development to prototyping and Manufacturing. HCL helps clients in Computer System Validation (CSV), Manufacturing Process Validation (Prospective, Retrospective and Concurrent), PMA, 510 (K), CE Marking, DHFs and Audits.
Regulatory Center of Excellence: HCL has a Regulatory Center of Excellence (CoE) which offers Consultancy services for Quality Systems implementation, Compliance, Risk assessment and mitigation. Proven methodologies and frameworks of HCL in the regulatory space is an asset to the clients. Medical Device specific quality management system (MQMS), based on ISO 13485, developed and implemented by HCL caters the requirements of regulatory bodies across the globe and serve as a compliance tool.
Pharmacovigilance: HCL provides a maintenance and support solution, KPO and help-desk solution, validation solution and Argus solution based on implementation, ASM, system validation, case processing, and aggregate reporting services. HCL offers a risk-based approach embracing recent FDA guidance, including 21 CFR Part 11, 21 CFR Part 210, Part 211 and Part 11 ER/ES Ruling interpretations and electronic data applications as pertaining to pharmaceutical industries' data acquisition, Electronic Batch Record, Audit Trail, Closed and Open Systems.
MQMS: HCL's Medical Device team has an unerring focus on quality, and considering the nature of the medical industry where safety is paramount, we have set up a Medical Quality Management System (MQMS). Focus on design and development process, project management, deployment via an intranet based system and induction training, MQMS training, ISO 13485, ISO 14971, IEC 62304 QSR awareness trainings etc.
To learn more about our pharmaceutical compliance testing solutions, contact us!