ISO 10993

ISO 10993:2018 is a globally recognized standard that outlines the biological evaluation of medical devices to ensure their biocompatibility and safety when in contact with the human body. As part of regulatory compliance, especially for CE marking and FDA approval, ISO 10993 plays a critical role in the risk assessment of medical devices.

At Quality Asia Certification, we support medical device manufacturers with ISO 10993 certification, ensuring that their products meet the necessary biological safety standards as per global regulatory requirements.

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What is ISO 10993?

ISO 10993:2018 is an international standard developed by the International Organization for Standardization (ISO) that provides a series of tests and guidance on evaluating the potential biological risks of medical devices. It covers the planning, execution, and documentation of biocompatibility testing, focusing on endpoints such as cytotoxicity, sensitization, irritation, genotoxicity, systemic toxicity, implantation, and more.

This standard is a crucial component in a medical device's risk management process and is applicable to a wide range of products including surgical instruments, dental materials, catheters, implants, and diagnostics.

Why is ISO 10993 important?

Medical devices come into direct or indirect contact with the human body, making biological safety a top concern. ISO 10993 provides a structured and scientific approach to identify and mitigate biological risks associated with these devices.

Here’s why your organization needs ISO 10993:2018 certification:

  1. Mandatory for Regulatory Approval: Required for CE marking in the EU and compliance with U.S. FDA regulations.
  2. Supports Risk Management: Aligns with ISO 14971 risk management principles to demonstrate product safety.
  3. Improves Market Access: Ensures international acceptability of your product in regulated and competitive markets.
  4. Strengthens Product Credibility: Demonstrates your commitment to health, safety, and quality.


What are the benefits of ISO 10993?

Implementing ISO 10993:2018 into your product development lifecycle results in numerous benefits, both technical and reputational:

  1. Enhanced Patient Safety: Minimizes adverse biological reactions by identifying and eliminating toxic risks.
  2. Comprehensive Test Guidance: Offers a clear roadmap for biological testing based on contact duration and device nature.
  3. Customizable Evaluation Strategy: Allows tailored assessments suited to the device’s intended use.
  4. Scientific Validation: Backed by rigorous testing protocols ensuring accurate and reliable results.
  5. Documentation Support: Ensures detailed and traceable records for audits and regulatory submissions.


What kind of businesses can benefit from ISO 10993?

ISO 10993:2018 certification provides a competitive edge for businesses in the medical device sector. Here’s how your business benefits:

  1. ✅ Faster Regulatory Approvals – Speeds up compliance for CE marking, FDA, and other international regulatory frameworks.
  2. ✅ Reduced Product Liability – Mitigates the risk of lawsuits or recalls by ensuring thorough biological risk evaluation.
  3. ✅ Global Market Access – Opens doors to export and international sales by complying with globally accepted standards.
  4. ✅ Increased Investor Confidence – Demonstrates product quality and regulatory maturity, enhancing trust from investors and stakeholders.
  5. ✅ Improved R&D Efficiency – Integrates biocompatibility assessments early in product design, reducing late-stage modifications.
  6. ✅ Brand Differentiation – Positions your company as a quality-focused and patient-safe organization in a competitive marketplace.


Top Tips on making ISO 9001 effective for you.

#1

Top management commitment while practicing and accomplishing the standard is the key to success.

#2

Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.

#3

Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.

#4

Review systems, policies, processes, and procedures for a smooth working of QMS.

#5

Speaking to customers & suppliers while getting feedback & working on improvements.

#6

Training staff carrying out the internal audits with the opportunity for improvement.

#7

Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.

#8

Ensure continuous improvement by regularly reviewing and updating your quality management practices.

#9

Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.

Why QualityAsia?

QualityAsia always vanguard in the auditing and governing of internationally acclaimed standards practices. At QualityAsia, we focus on driving the success of our clients through creating excellence with our trained professional auditors. The content of our service provision, comply with international certification rules defined by the accreditation bodies without burning a hole in your pocket. We will take you through the journey of audits with our best kept audit practices, viz.:

Initial Certification – Stage 1 (Preparatory Phase)
  • Thorough documented information review.
  • Exchange of information with staff through online or onsite presence.
  • Identification of key performances, processes & objectives as per the standard requisites.
  • Analysis of facilities, infrastructure, systems and processes in regard with the requested certification scope with a resource allocation review.

Initial Certification – Stage 2 (On-site Audit)
  • Measurement, reporting & reviewing the performances against key performances objectives.
  • Reviewing the suitability of the system meeting the legal, regulatory & contractual requirements.
  • Operational control of processes, internal audits & management reviews while understanding the responsibilities for the policies.
  • Conclusion based on prescriptive requirements, policy, performance objectives, staff skill, operations, procedures, internal audits, etc.


    Surveillance & Certification Renewal

    Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.

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