Crafting a Symphony of Medical Excellence, Where Quality and Compliance Harmonize for Safer Healthcare Solutions
ISO 13485 is the international standard for quality management systems in the medical device industry. It sets out requirements for organizations involved in the design, production, and distribution of medical devices, ensuring they adhere to strict quality and regulatory standards to deliver safe and effective products. Compliance with ISO 13485 is crucial for enhancing product quality, patient safety, and regulatory compliance in the healthcare sector.
ISO 13485 helps organizations in the medical device industry establish and maintain robust quality management systems, leading to the production of high-quality and safe medical devices.
Compliance with ISO 13485 aligns with regulatory requirements in the medical device industry, facilitating market access and reducing the risk of regulatory issues.
The standard's emphasis on risk management ensures that organizations identify and mitigate potential risks associated with medical devices, contributing to patient safety and regulatory compliance.
ISO 13485 certification is widely recognized internationally, enhancing an organization's credibility and facilitating market access by demonstrating adherence to global quality and regulatory standards.
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Explore our Frequently Asked Questions (FAQs) to gain a deeper understanding of ISO Certification. our guide provides insights into the certification process, its benefits, and how it can elevate your organization. Whether you’re a small business or a larger enterprise, find answers to common queries about timelines, costs, and the steps needed to embark on your journey towards ISO Certification excellence.
ISO 13485:2016 certification is not mandatory; although it brings your practices up to date with standard requirements that exist across the country, the EU and globally which very well may be mandatory.
Companies manufacturing medical devices often find that the consultancy of expert specialist helps them to easily implement ISO 13485:2016 into their core processes.
At Our, our consultants work directly with you to ensure your QMS works for your organization. We help you design your control requirements in line with the standard, then submit you to a recognized, third-party certification body who will audit your business and get you ISO 13485:2016 certified.
The time taken to get ISO 13485:2016 certified depends on the size, nature and complexity of your organization. It is estimated that it can take 6-8 weeks for companies with less than 50 employees. For larger companies, it can take 10-12 weeks as complex manufacturing processes like sterilization time consuming process.
Organizations initiate the ISO 13485 certification process by understanding the standard's requirements, conducting a gap analysis, and developing an implementation plan to align their quality management system with ISO 13485 principles.
This stage involves establishing and implementing quality management system processes, procedures, and controls outlined in ISO 13485. Organizations train employees and create documentation to support their compliance with the standard.
An internal audit is conducted to assess the effectiveness of the implemented quality management system. Findings are addressed to ensure alignment with ISO 13485 requirements and continual improvement.
An external certification body conducts a final audit to verify the organization's compliance with ISO 13485 standards. Successful completion results in ISO 13485 certification, demonstrating the organization's commitment to quality and regulatory compliance in the medical device industry.
