Consultants for Medical Device Certification – Specialists in ISO 13485 and Quality Management Systems
At Medos, we are experienced ISO 13485 consultants offering tailored business development services for companies in the medical device industry. Our mission is to help you build, improve, and maintain a quality management system (QMS) that meets both regulatory requirements and business objectives. Whether you're in the early startup phase or looking to enhance an existing QMS, our ISO 13485 consultants are ready to guide you through the entire process—from GAP analysis to audits and certification.
ISO 13485 Consulting Services for Medical Device Companies
ISO 13485 is the international standard for quality management systems specific to medical devices. Achieving ISO 13485 certification requires a thorough understanding of the regulatory framework and its practical implementation. Our ISO 13485 consultants help you identify areas for improvement, develop the necessary documentation, and adapt your processes to meet current requirements—with a clear focus on efficiency, safety, and regulatory compliance.
Medos offers services including:
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GAP analyses against ISO 13485:2016
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Development and review of quality manuals and procedures
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Implementation of processes for CAPA, internal audits, design control, and more
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Support before and during certification audits
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Regulatory consulting for MDR and IVDR compliance
We can function as an external resource or an integrated part of your team, depending on your needs. Our consultants have deep industry experience and work with everything from startups to well-established medical device manufacturers.
ISO 13485 Certification – A Key to Global Growth in Medtech
Obtaining ISO 13485 certification is often a prerequisite for selling medical devices in both European and global markets. It also serves as clear proof to customers, authorities, and partners that your organization has control over product quality, risk management, and regulatory compliance. Our consultants support you throughout the entire certification journey and ensure that your QMS becomes not just compliant—but a valuable tool for continuous improvement.
We make sure your management system works in practice, not just on paper. By working with our ISO 13485 consultants, you ensure that certification leads to real-world benefits—from reduced non-conformities and improved product quality to greater market acceptance.
Consulting Support for Integrated Management Systems and Related Standards
In addition to ISO 13485, our consultants also provide guidance on other standards that influence management systems in the medtech industry, such as:
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ISO 14971 – Risk management for medical devices
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ISO 9001 – General quality management, often integrated with ISO 13485
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IEC 62304 – Software lifecycle processes for medical device software
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ISO 14155 – Clinical investigations of medical devices
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IEC 81001-5-1 – Cybersecurity for health IT and medical devices
These standards often form essential parts of a cohesive quality management system. Our consultants help you identify which standards are relevant for your business and how to integrate them efficiently and effectively.
Your Long-Term Partner for ISO 13485 Consulting and Medical Device Certification
Medos is more than just a consultant—we are your strategic partner in achieving ISO 13485 certification and ensuring long-term regulatory compliance in the medical device field. We believe in close collaboration, clear communication, and practical solutions. With our consulting support, you can be confident that your QMS is robust and resilient, even in a rapidly changing regulatory landscape.
Choose Medos as your ISO 13485 consultant and take the next step toward becoming a certified, scalable, and quality-driven medtech company. Contact us today for a free initial consultation.
