Quality Management Consulting

Young woman using magnifier at quality check station at factory producing flexible electronic circuit boards. Plant is located in the south of China, in Zhuhai, Guangdong province

Quality Management Consulting for Medical Devices

Ensuring Compliance & Certification for Global Market Access

At Isha’s GMP Consultancy, we help medical device manufacturers implement and enhance Quality Management Systems (QMS) in compliance with ISO 13485 (EU), 21 CFR Part 820 (U.S.), ICMED 13485 (India), and other global standards.

A strong QMS ensures regulatory compliance, improves product quality, and facilitates smooth certification approvals. Our expert team provides end-to-end QMS consulting, audits, validation, and training to help you achieve seamless compliance and operational excellence.

Our QMS Consulting Services
Quality System Implementation & Compliance
  • QMS development, review, and maintenance for global regulatory requirements
  • Gap analysis to identify compliance weaknesses and improvement areas
  • ISO 13485, 21 CFR Part 820, ICMED 13485 compliance support

Audits & Certification Support

  • Internal audits, vendor audits, and pre-assessment audits
  • Preparation & support for certification assessments by regulatory authorities
  • Coordination with Notified Bodies for compliance approvals

Equipment & Process Validation

  • Equipment Qualification (IQ, OQ, PQ)
  • Process validation for regulatory compliance
  • Continuous QMS monitoring & improvement strategies

Training & Regulatory Support

  • QMS & audit training for internal teams
  • Regulatory liaison for seamless compliance processes
  • Serving as your Internal Quality Consultant for long-term QMS support

Why Choose Isha’s GMP Consultancy?

  • Expert-driven compliance solutions for medical device manufacturers
  • Tailored QMS strategies for smooth regulatory approvals
  • End-to-end audit preparation & validation support
  • Proven experience in ISO 13485, 21 CFR Part 820 & ICMED 13485 standards

Contact us today to strengthen your Quality Management System and achieve global certification success!

Medical Device