Quality Control Certification (QCC) allows medical device manufacturers to receive global recognition for their dedication to quality. We walk you through the ISO 13485:2016 certification process, guaranteeing that your products meet the toughest safety and performance requirements. Partner with Quality Control Certification for an easier, faster path to ISO 13485 certification.

What is ISO 13485:2016 Certification?

ISO 13485:2016 sets the global standard for quality management in medical devices. It establishes comprehensive standards for the design, development, production, and distribution of medical devices that consistently meet regulatory standards while prioritizing patient safety.
Benefits of ISO 13485:2016 Certification:

  • Better Patient Safety: A strong QMS promotes consistent quality throughout the medical device lifecycle, reducing risks and failures.
  • Increased Market Access: ISO 13485:2016 certificate demonstrates your dedication to quality and opens doors to new markets and worldwide relationships.
  • Improved Regulatory Compliance: A compliant quality management system makes it easier to navigate complex medical device laws.
  • Streamlined Quality Management Processes: ISO 13485:2016 encourages efficiency and effectiveness in quality management practices.
  • Boosted Customer Confidence: Certification symbolizes your commitment to quality, instilling trust and confidence in your customers.

Eligibility for ISO 13485:2016 Certification

Any organization involved in the life cycle of a medical device is eligible for ISO 13485 certification. This includes manufacturers, distributors, and companies that provide medical device-related services such as disinfection or packing.

Process of Getting an ISO 13485 Certificate

Having an ISO 13485 certification demonstrates your dedication to quality. Let's walk you through the steps to achieving ISO 13485:2016 certification.

  1. Initial Contact: Discuss your requirements with Quality Control Certification and obtain free advice.
  2. Gap Analysis: Assess your current QMS against ISO 13485:2016 requirements.
  3. QMS Development & Implementation: Develop and implement a compliant quality management system with QCC's guidance.
  4. Management System Review: Conduct an internal review to ensure your QMS is effective.
  5. Pre-Assessment Audit (Optional): Identify potential non-conformities before the formal audit.
  6. Formal ISO 13485 Certification Audit: An accredited certification body audits your QMS.
  7. Certification Decision: Receive the certification upon successful completion of the audit.
  8. Ongoing Surveillance Audits: Maintain your certification with regular audits by the certification body.
  9. Continuous Improvement: Continuously improve your QMS for optimal performance.
  10. Recertification: Renew your certification every three years.

Why Choose QCC for ISO 13485:2016 Certification?

  • Quality Control Certification (QCC) is a leading provider of ISO certification services for medical device companies.
  • Our team consists of highly qualified auditors with extensive experience in the medical device industry and in-depth knowledge of ISO 13485:2016 requirements.

We offer a comprehensive and streamlined approach to ISO certification, ensuring a positive experience for your organization. Here's what sets us apart:

  • Streamlined Certification Process: Our efficient procedures minimize disruption to your operations.
  • Cost-Effective Solutions: We offer competitive pricing and flexible packages to suit your budget.
  • Personalized Guidance and Support:We provide dedicated guidance throughout the certification journey.
  • Proven Track Record:We have a well-established reputation for successful ISO certification.

Benefits of ISO 13485 Certification with QCC

Partnering with QCC for ISO 13485 certification empowers you to achieve:

  • Enhanced Patient Safety: A robust QMS mitigates risks and ensures the safety and efficacy of your medical devices.
  • Increased Market Access: Gain a competitive edge and access new markets with globally recognized certification.
  • Improved Regulatory Compliance: Navigate complex regulations with confidence.
  • Streamlined Operations: Optimize your quality management processes for efficiency and cost-effectiveness.
  • Boosted Customer Confidence: Demonstrate your unwavering commitment to quality and build trust with customers.