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Electronic Chip

ISO 13485


Achieving ISO 13485 certification is a crucial step for companies operating in the medical device industry. This internationally recognized standard sets forth the requirements for a quality management system specific to medical devices, ensuring compliance with regulatory bodies and demonstrating a commitment to product safety and quality. 

At My ISO Consultants, we specialize in providing comprehensive ISO 13485 and 21 CFR 820 consulting services to help medical device companies streamline their processes, meet regulatory requirements, and enhance overall performance. Our team of experienced consultants is dedicated to guiding you through the certification process and supporting your organization's quality management journey. 

Why Choose Us?

  • Expertise: Our consultants have extensive knowledge and experience in the medical device industry. We stay up-to-date with the latest regulations and industry best practices to ensure that your organization receives the most relevant and accurate guidance. 

  • Tailored Solutions: We understand that every organization is unique, with its own specific needs and challenges. Our consulting services are customized to address your organization's requirements, taking into account its size, complexity, and existing quality management system. 

  • Comprehensive Approach: We offer end-to-end consulting services, from initial assessment and gap analysis to the development and implementation of a robust quality management system. Our goal is to provide a seamless and efficient process that minimizes disruption to your operations. 


Our Services:

  • ISO 13485 and 21 CFR 820 Gap Analysis: Our consultants will conduct a thorough review of your existing quality management system to identify any gaps or areas of non-compliance with ISO 13485 requirements. We will provide you with a detailed report outlining the necessary steps to achieve certification. 

  • Documentation Development: We will assist you in developing all the required documentation, including policies, procedures, work instructions, and forms. Our consultants will ensure that your documentation meets the specific requirements of ISO 13485 with 21 CFR 820 and is tailored to your organization's operations. 

  • Implementation Support: We will guide you through the implementation of your quality management system, helping you establish the necessary processes and controls. Our consultants will provide training to your staff to ensure a smooth transition and effective adoption of the new system. 

  • Internal Audits: Regular internal audits are essential to maintaining ISO 13485 and 21 CFR 820 compliance. Our consultants will conduct internal audits to assess the effectiveness of your quality management system and identify areas for improvement. We will provide you with detailed reports and recommendations to drive continual improvement. 

  • Certification Preparation: Our team will support you throughout the certification process, working closely with the certification body to ensure a successful outcome. We will help you prepare for the certification audit, addressing any non-conformities and guiding you in implementing corrective actions. 

  • Post-Certification Support: After achieving ISO 13485 certification, we will continue to assist you in maintaining compliance and improving your quality management system. Our consultants will provide ongoing support, conduct follow-up audits, and help you address any emerging challenges or changes in regulations. 

Take the Next Step

Partner with My ISO Consultants to streamline your quality management system, ensure compliance with ISO 13485 and 21 CFR 820, and enhance your organization's overall performance. Contact us today to schedule a consultation and discover how our expert consultants can help you achieve your certification goals. 

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