The medical device industry is highly regulated, and rightly so. There are many moving pieces, and the landscape of this industry keeps changing, making it challenging for organizations to keep up with the requirements set forth by the government to ensure regulatory compliance, customer satisfaction, and risk management. ISO 13485 is an international standard that fulfills this requirement of quality management systems in the medical device industry. ISO 13485 standards for regulatory requirements are also well aligned with FDA and EU medical device regulations. In fact, if an organization has implemented ISO 13485 certification, the FDA and EU take it into consideration and utilize the documentation and implementation of the overlapping areas of the certification.

In the ISO 13485 certification, an organization will go through a rigorous process of implementation of the certification and then get certified by a third-party audit. Getting an ISO 13485 certification can bring numerous benefits, such as helping organizations grow their operational efficiency, improving customer satisfaction, implementing process controls to improve product quality and safety, providing a boost to business growth, and presenting new opportunities. Finally, it will give access to new markets, and getting ISO 13485 certified will give your organization a chance to partner with other medical device industries.

With limited experience and resources, it's a herculean task to get ISO 13485 certification on your own. With the expert guidance of an experienced consultant, the process of certification can be simplified and streamlined. It ensures that compliance is achieved effectively and certification is granted successfully. MG’s seasoned consultants are experts in getting medical devices or parts ISO 13485 certified. They will provide comprehensive solutions to the ISO 13485-related issues with a tailored approach and cost-effective efforts. When MG’s consultants come on board, we ensure that organizations understand the tasks, costs, and benefits associated with the certification. We are also local to the San Francisco Bay area medical device companies, and for any ISO 13485 certification needs in the San Francisco Bay Area, we come on-site for gap analysis, in-person meetings, or to address issues on short notice.

Below is the process that MG follows to help our clients get ISO 13485 certified.

Understanding the ISO 13485 requirements: ISO 13485 certification can be very complex because a lot of the requirements are based on the design, development, production, installation, and servicing of the devices and parts your organization is working on. It is important to understand the requirements and standards that are applicable to you. MG’s consultants will make sure you understand the requirements and applicability of the certification.

Gap analysis and risk assessment: After understanding the ISO 13485 requirements for your business, our consultants will conduct a thorough gap analysis and find gaps between existing practices and the standard requirements. This is the most crucial stage of the certification. This involves a review of the documentation for each process control applicable to design, development, production, shipping, and servicing. It will also involve finding areas of the organization that are not in compliance with regulatory requirements. This stage will help the consultants establish the scope of work, timeline, and cost of the certification. It also helps them prepare a roadmap for implementing the quality management system with effective use of resources.

Implementation of the quality management system, or ISO 13485,: MG’s consultants will prioritize streamlining every process and control, and while doing that, they will develop and document policies, procedures, work instructions, and other relevant documents. We will also establish training programs, conduct employee training, and implement a continuous improvement plan. MG’s consultants will thoroughly look into each requirement of the ISO 13485 certification and implement the changes needed to be in compliance with the regulations of this certification.

Third-party audit and post-audit support: The final step in the certification process is getting audited by an accredited certification body. A third-party auditor will come on-site to evaluate the organization's compliance with the ISO 13485 standards’ requirements. The auditor will review documents, interview employees, and prepare a final audit report. Upon successful completion of the audit, possible outcomes can be a pass, a pass with minor non-conformities, or a no-pass with minor or major non-conformities. MG’s consultants have a track record of successful standard implementation and audits. If you partner with us, you will get a 100% pass on the audit of ISO 13485 certification. We also provide post-audit support to help you stay in compliance and implement the culture of continuous improvement. Organizations must work towards continually improving their product quality, services, and customer satisfaction.

By following the steps above, MG will ensure that your journey towards achieving ISO 13485 certification is smooth and successful. We focus on bringing value for money and other benefits to your organization. We have partnered with many companies around the world, specifically in the San Francisco Bay Area, for ISO 13485 certification and understand the state and federal regulations for the medical device industry very well. Contact us at 510-332-1321 or visit us at www.mgenviro.com for quotes or queries.

Contact US: + 1-510-332-1321
Email:- [email protected]
Website:- https://mgenviro.com/iso-13485-certification/