MS Certification Services

ICMED 13485 /ICMED 13485 PLUS

Elevate Your Medical Device Compliance with ICMED Certification

At Alpine Quality Consultants, we specialize in helping medical device manufacturers achieve ICMED 13485 and ICMED 13485 Plus certification. As India's first indigenous quality certification system for medical devices, ICMED enhances product credibility, compliance, and market access. Our expert consultancy services ensure a smooth and efficient certification process tailored to your business needs.

Understanding ICMED 13485 & ICMED 13485 Plus

ICMED 13485 aligns with ISO 13485, focusing on quality management systems for medical devices, ensuring regulatory compliance and product safety.

ICMED 13485 Plus includes additional requirements for product certification, offering an enhanced level of trust and quality assurance in the Indian medical device market.

Our Consultancy Services

We provide end-to-end support for ICMED certification, including:

Gap Analysis & Readiness Assessment

  • Initial evaluation of your current quality management system
  • Identification of gaps against ICMED 13485 & ICMED 13485 Plus requirements
  • Strategic roadmap for compliance improvement

Documentation Support

  • Development and review of Quality Manuals, SOPs, and required documentation
  • Assistance in creating technical files and regulatory documents
  • Risk management and post-market surveillance documentation

Implementation & Training

  • Hands-on guidance in implementing ICMED 13485 standards
  • Employee training on compliance, quality management, and best practices
  • Mock audits and workshops to ensure seamless implementation

Internal Audits & Certification Assistance

  • Conducting internal audits to assess readiness
  • Support during certification audits by accredited bodies
  • Post-certification compliance monitoring and continuous improvement
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

Links

Services

Contact

BH-403, Fourth Floor 81 High Street, Business Hub, Sector 81, Faridabad, Haryana 121002, India

© Alpine Quality Consultants 2025 | All Rights Reserved

TOP