ISO 13485:2016 Certification

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ISO 13485:2016 Certification Services

Comprehensive Quality Management System (QMS) Support for Medical Device Companies

At Isha’s GMP Consultancy, we specialize in helping medical device companies achieve ISO 13485:2016 certification through a structured, hands-on approach. With extensive industry experience, we guide organizations through QMS development, implementation, training, audits, and certification processes.

Our ISO 13485:2016 Consulting Services
Quality Management System (QMS) Development & Implementation
  • Gap Analysis – Identify areas that need improvement to meet ISO 13485 requirements.
  • QMS Planning & Documentation – Develop standard operating procedures (SOPs), work instructions, and policies.
  • Implementation Support – Ensure seamless adoption of QMS in day-to-day operations.

Ongoing System Maintenance & Support

  • QMS Updates & Compliance Management – Stay aligned with regulatory changes.
  • Corrective & Preventive Actions (CAPA) – Address non-conformities and improve system efficiency.
  • Process Optimization – Improve productivity and streamline operations.

Internal Audits & Management Reviews

  • Pre-Certification Internal Audits – Ensure readiness for external audits.
  • Management Review Meetings – Support leadership in reviewing QMS effectiveness.
  • Supplier & Supply Chain Audits – Evaluate vendor compliance & quality performance.

Employee Training & Skills Development

  • ISO 13485 Awareness Training – Educate employees on the importance of QMS.
  • Internal Auditor Training – Equip team members with audit skills for continuous compliance.
  • Regulatory & Quality Training – Cover risk management, CAPA, and document control.

Certification & Surveillance Audit Support

  • Assistance in Certification Audit Preparation – Ensure successful initial ISO 13485 certification.
  • Support During Surveillance & Re-Certification Audits – Maintain compliance and continuous improvement.
  • Liaison with Certification Bodies – Assist in coordinating with notified bodies & regulatory authorities.

Why Choose Isha’s GMP Consultancy?

  • Industry Experts – Extensive experience in medical device QMS implementation.
  • Tailored Solutions – Custom support based on your organization’s needs.
  • End-to-End Support – From QMS setup to certification & post-certification maintenance.
  • Regulatory Compliance – Ensuring adherence to global medical device regulations.

Contact us today to achieve ISO 13485:2016 certification and enhance your compliance & quality excellence!

Medical Device