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Regulatory Compliance

Industry Challenges

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

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.

HCL helps clients in Computer System Validation (CSV), Manufacturing Process Validation (Prospective, Retrospective and Concurrent), PMA, 510 (K) ), CE Marking, DHFs and Audits.

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.

HCL Regulatory and Compliance Excellence Services

HCL solutions cover the full suite of regulatory and compliance requirements. It provides its clients:

  • Well Structured Methodology for ensuring Compliance
  • Compliance Gap Analysis
  • Remediation of Applications for Regulatory Compliance
  • Code sets and Identifiers
  • EDI Transactions
  • Privacy and Security Requirements Implementation
  • Compliance Testing
  • Faster, more efficient review of labeling submissions

HCL Differentiators

  • One stop shop for Consultancy Services, Solution Implementations, Submissions, Audits and Process Definitions
  • First offshore vendor to be certified for ISO: 13485
  • The vertical has a deep understanding of the business domain and there are many professionals who are certified to the specific industry certifications like HL7, HIPAA and SOX etc
  • The professionals, with an average of 7-10 years of industry experience, provide functional solutions, with the assistance from the core technological superiority of HCL Technologies in supporting these solution frameworks
  • Complete awareness about upcoming as well as current regulations like 21-CFR-Part 11 and Part 820
  • Clear understanding of Documentum product roadmap because of Product Engineering relationship with Documentum
  • Consultants who are members of RAPS (Regulatory Affairs Professional Society)

The payback for the organization comes in a number of ways:

  • Faster and easier compliance through a robust, tool-based approach
  • Higher quality compliance
  • Significant cost reduction and value add in project portfolio management
  • Opportunities to improve/enhance systems and processes
  • Ability to leverage compliance needs for re-engineering and e-business initiatives

What Customers Say

"HCL is our key partner for medical devices development. Several of our projects are conducted at their design center in Chennai, India. For us, India represents much more than those aspects of IT. Today, we rely on our partner for critical, real-time control software as well as complex hardware design encompassing digital and analog electronics."
- Vice President, R&D Worldwide, a leading medical devices company


"Since we hardly had any internal knowledge of the MES topic, HCL was able to apply their knowledge and our requirements to thoroughly sift through the large number of choices so that our company can make the most informed decision possible for our MES software selection process. They are now leading many deployment activities while working with the software vendor."
- Customer Project Sponsor, Leader in Medical Devices