Get ISO 13485:2016 Certification in India – Medical Device Quality Management System (QMS)

Looking to meet international standards for medical device quality? ISO 13485:2016 certification is the globally recognized standard for Quality Management Systems (QMS) in the medical device industry. At Easy Go Certifications, we provide a 100% online, expert-guided, and cost-effective certification service across India. Ensure global compliance, enhance product safety, and boost market access.

ISO 13485:2016 Certification – Overview & Key Benefits

What is ISO 13485:2016 Certification?

ISO 13485:2016 is an internationally recognized quality standard specifically tailored for organizations involved in the design, manufacturing, installation, and servicing of medical devices. It ensures compliance with global regulatory requirements and helps manage risk throughout the product lifecycle.

Whether you're a medical device manufacturer, supplier, or service provider, Easy Go Certifications makes your certification journey seamless through expert consultation, end-to-end documentation support, and a fast online certification process.

Key Benefits of ISO 13485:2016 Certification

  1. Regulatory Compliance: Aligns with global frameworks like EU MDR and US FDA 21 CFR Part 820, supporting smooth product approvals.
  2. Enhanced Product Quality and Patient Safety: Helps reduce defects and maintain consistent product standards.
  3. Global Market Access: Certification is often a prerequisite for exporting to regulated markets in Europe, North America, and beyond.
  4. Boosted Customer Trust and Credibility: Assures healthcare professionals and partners of your commitment to quality and safety.
  5. Improved Operational Efficiency: Streamlines internal processes and minimizes non-conformities through systematic quality control.
  6. Supports Continual Improvement: Fosters a culture of ongoing improvement through audits, metrics, and risk-based thinking.

OUR SERVICES

ISO 9001:2015 defines global standards for quality management systems.

ISO 14001:2015 sets global standards for environmental management systems.

ISO 22000:2018 ensures food safety and quality in organizations.

Improves processes, reduces errors, and enhances overall customer satisfaction.

ISO 45001 defines global standards for occupational health and safety management.

Provides framework for organizations to establish anti-bribery management systems.

ISO 13485:2016 is a certification standard for medical devices.

ISO 20000:2011 sets standards for effective IT service management.

DOCUMENTATION REQUIREMENTS

Business Registration Proof

Sale & Purchase Invoice

Scope of Business

Get Approval

CONTACT US

Address

407/a unicity business park, zirakpur 140603

Open Hours

9AM - 6PM

Become ISO Certified Now