ISO 13485 Certification
DoStartup is here to assist you in getting ISO 13485 certification to ensure that you comply with the International Standards set for Quality Management systems for the development, production, instal.
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Overview of ISO 13485 Certification
In the medical device industry, safety and quality are non-negotiable. ISO 13485 Certification defines the requirements for a Quality Management System (QMS) specific to organizations involved in the design, production, storage, distribution, servicing, and related services of medical devices. This standard also applies to suppliers and external providers involved in these processes. ISO 13485 is based on ISO 9001 (earlier version) and provides internationally accepted guidelines for QMS. Although released after ISO 9001’s major update, ISO 13485 does not align with ISO 9001:2015, as the changes in ISO 9001 were considered unnecessary for the medical device sector. Recognized globally, ISO 13485 Certification validates compliance with regulatory and quality expectations and is often required through third-party certification for manufacturers, developers, and service providers in the healthcare space.
Structure of ISO 13485
This standard is divided into eight sections: The first three are introductory, while the last five are mandatory QMS components: Quality Management System, Management Responsibility, Resource Management, Product Realisation, and Measurement, Analysis, and Improvement.
Key Revisions in ISO 13485
ISO 13485:2016 replaces ISO 13485:2003 and 13485:2012. It was published on March 1, 2016, and is aligned with ISO 9001:2008, not ISO 9001:2015. The standard is managed by ISO Technical Committee 210 to ensure relevance and accuracy.
Benefits of ISO 13485 Certification
• Internationally recognized QMS standard (EN ISO 13485) • Broader product and market access • Easier transition into specialized certifications • Clear insights into QMS performance • Greater regulatory compliance • Identification of risk and non-compliance areas • Trusted certification and reporting • Strong foundation for future growth • Better understanding of device-specific requirements
1. Prerequisites for ISO 13485 Certification
To qualify, your organization must meet:
• General Requirements: Full adherence to ISO 13485 standard, documented procedures, risk assessment, monitoring, and compliance (including when outsourcing), and effective operations tracking.
• Documentation Requirements: Maintain a Quality Manual & Policy, medical device file, control plans, management review reports, training procedures, and protocols for design, risk, and purchasing.
• Management Responsibility: Demonstrate commitment to regulations, customer focus, strategic planning, delegation, communication, and periodic reviews.
• Resource Management: Ensure skilled staff, infrastructure, equipment, succession planning, and regulatory support.
• Product Realisation: Plan, document, and validate every step from concept to production and testing.
• Measurement, Analysis, and Improvement: Address complaints, conduct audits, and drive continuous improvement.
2. Documents Required for ISO 13485 Certification
Organizations must prepare documentation for:
• Regulatory roles and responsibilities
• Quality Manual, Policies, and Objectives
• Design and development files, plans, and changes
• Risk management and control records
• Traceability, product cleanliness, and installation verification
• Audit reports, internal reviews, and calibration records
• Customer feedback and complaint handling
• Preventive and corrective action plans
3. Procedure to Obtain ISO 13485 Certification
To get certified with Do Startup, follow these four steps:
1. Optional Preliminary Audit: Site inspection and documentation review to evaluate readiness.
2. Stage I Audit: On-site assessment of business eligibility and QMS documentation.
3. Stage II Audit: In-depth evaluation of real-time QMS implementation and efficiency.
4. Certification: Issuance of official ISO 13485 Certificate after full compliance.
4. Do Startup’s Role in ISO 13485 Certification
Let Do Startup make your ISO 13485 journey simple:
• Choose a service plan
• Share your queries and requirements
• Submit necessary documents
• Meet all pre-certification criteria
• Complete certification formalities
• Receive your certificate with full support!