Overview
The legal landscape of the Medical Device industry is extremely dynamic in nature. To successfully traverse this landscape, firms require 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 business processes
Our Regulatory Excellence Services span all the Life Sciences industries (Medical devices, Pharmaceutical & Biotech Industries and Healthcare). We address the entire value chain of Medical Device companies starting from Research & Development to prototyping and Manufacturing.
Solutions
Compliance
Modern medical device companies are grappling with several legal complexities and stringent policy requirements. To perform in-sync with industry norms, enterprises need robust intellectual property capabilities and compliance consultancy services. HCLTech helps streamline the entire value chain for medical device companies – from research and development (R&D) to prototyping and manufacturing. HCLTech also offers key solutions for Computer System Validation (CSV), Manufacturing Process Validation (Prospective, Retrospective and Concurrent), PMA, 510 (K), CE Marking, DHFs, and Audits.
Regulatory Center of Excellence
HCLTech has established a state-of-the-art Regulatory Center of Excellence (CoE) to design consultancy frameworks – geared for quality systems implementation, compliance systems, risk assessment, and mitigation. Clients can harness HCLTech’s proven methodologies in the regulatory space to optimize existing processes – such as the Medical Device specific quality management system (MQMS), based on ISO 13485, which serves as an end-to-end compliance tool.
Pharmacovigilance
From ideation to launch, an average drug demands investment in the range of USD 1 billion. To prevent recalls in this scenario, HCLTech provides end-to-end services for predictive and proactive pharmacovigilance – comprising Argus, KPO, help-desk, validation, maintenance, and support.
MQMS
HCLTech is committed to maintaining best-in-class quality and safety standards. It has developed and implemented a Medical Device specific quality management system (MQMS), in accordance with recent medical industry safety regulations, to address compliance requirements of leading enterprises across the globe. With a focus on design and development processes as well as project management and rollout, HCLTech’s dedicated medical device team utilizes an intranet based system and specialized training sessions. Other areas of focus include MQMS training, ISO 13485, ISO 14971, IEC 62304, and QSR awareness.
