ISO 13485 Certification Services for Medical Device Companies

ISO 13485 CERTIFICATION SERVICES

✔️ A team of experienced specialists with in-depth knowledge of the medical device industry

✔️ Flexible audit scheduling aligned with the company’s production and business plans

✔️ ISO 13485 certificates issued by SQS Global are internationally recognized through accreditation under BoA and IAF

✔️ A single point of contact for ISO 13485 training, auditing and certification services

✔️ A clear implementation roadmap from initial gap assessment through certification audit, helping minimize delays and unexpected costs

✔️ Supporting businesses in obtaining ISO 13485 certification efficiently and maximizing the commercial value of certification

GET A FREE QUOTATION

TALK TO OUR EXPERTS

ISO 13485 CERTIFICATION SERVICES

✔️ A team of experienced specialists with in-depth knowledge of the medical device industry

✔️ Flexible audit scheduling aligned with the company’s production and business plans

✔️ ISO 13485 certificates issued by SQS Global are internationally recognized through accreditation under BoA and IAF

✔️ A single point of contact for ISO 13485 training, auditing and certification services

✔️ A clear implementation roadmap from initial gap assessment through certification audit, helping minimize delays and unexpected costs

✔️ Supporting businesses in obtaining ISO 13485 certification efficiently and maximizing the commercial value of certification

GET A FREE QUOTATION

ISO 13485 Certification – Medical Device Quality Management System

ISO 13485 is an internationally recognized Quality Management System (QMS) standard specifically developed for the medical device industry. It establishes requirements for organizations to consistently provide safe and effective medical devices while complying with applicable regulatory requirements.

Products commonly covered under ISO 13485 include:

Medical gloves and surgical masks
Disinfectants and sterilization solutions
Syringes, infusion sets and feeding tubes
Diagnostic, laboratory and other medical devices

ISO 13485 Certification Services for Medical Device Manufacturers

SQS Global provides consulting, training, auditing and certification services for ISO 13485:2016 – the international standard for Medical Device Quality Management Systems. Certifications issued by SQS Global are recognized through internationally accredited frameworks, helping organizations strengthen quality management, control risks, meet regulatory requirements and enhance credibility with customers and business partners.

Xây dựng hệ thống ISO 13485 - Quản lý chất lượng sản xuất

ISO 13485 System Development

Conduct gap assessments, develop quality management procedures and establish the documentation required to comply with ISO 13485 requirements.

Internal Auditor Training

Provide ISO 13485 internal auditor training programs to help organizations effectively conduct internal audits and maintain compliance within medical device operations.

ISO 13485 Certification

Support organizations in completing documentation, undergoing certification audits and maintaining certification validity through surveillance and recertification activities.

Register for ISO 13485 Certification with SQS Global

Benefits for organizations registering for ISO 13485 certification with SQS Global:

✔️ Free initial consultation and gap assessment to evaluate current compliance levels

✔️ Guidance on an ISO 13485 implementation roadmap tailored to your organization’s size and scope of activities

✔️ Support in understanding regulatory and compliance requirements related to medical device manufacturing and distribution

✔️ Complimentary ISO 13485 readiness checklist to assess preparedness before implementation

✔️ Complimentary templates and reference documents to support the development of your quality management system

✔️ Ongoing guidance and support throughout the certification preparation and audit process

==> Submit the form today for prompt assistance from our experts!

Information About ISO 13485 Certification Services

Due to the specific requirements of the medical device industry, the ISO 13485 certification audit is conducted directly at the manufacturing facility or operational site of the organization. Following the initial assessment, SQS Global experts will review applicable requirements, identify any gaps and provide guidance on documentation preparation and implementation planning.

Organizations may refer to the following information regarding certification costs and implementation timelines:

Certification Cost: Depending on the organization’s size, certification scope and current maturity of the quality management system.
Implementation Timeline: Typically 30–90 days, depending on the organization’s level of readiness and resource availability.

Note: For organizations requiring EN ISO 13485 certification or English-language certification documentation for international markets, additional requirements and costs will be reviewed based on the specific project scope.

Other Related Certifications

ISO 13485 certification is a key requirement for organizations involved in the design, manufacture and distribution of medical devices. It demonstrates the organization’s ability to maintain an effective quality management system and comply with applicable regulatory requirements.

In addition to ISO 13485 certification, organizations may also need to obtain other regulatory approvals and certifications, including:

Certificate of Free Sale (CFS)
ISO 9001 Quality Management System Certification
Regulatory licenses and approvals related to medical device manufacturing, importation and distribution in accordance with local regulations.

ISO 13485 Certification Process & Registration Procedure at SQS Global

The ISO 13485 certification process at SQS Global consists of six key stages and is conducted by experienced professionals with extensive knowledge of the medical device industry. Our approach helps organizations establish an effective quality management system, complete required documentation and prepare for certification successfully.

Step 1: Initial Assessment & Gap Analysis

SQS Global works directly with the organization to assess the current quality management system, manufacturing processes and existing documentation. Based on the findings, our experts identify improvement opportunities and develop an implementation roadmap aligned with operational requirements.

Step 2: ISO 13485 System Development

Once the implementation scope is defined, SQS Global supports the development of procedures, forms and documentation required by ISO 13485. The organization collaborates by providing operational information to ensure the system reflects actual business practices.

Step 3: Training & Implementation

SQS Global delivers ISO 13485 awareness and implementation training programs to help employees understand their responsibilities, operational procedures and quality management requirements within the medical device industry.

Step 4: Internal Audit & System Improvement

Before certification assessment, SQS Global conducts an internal audit to evaluate system effectiveness. Any identified nonconformities are analyzed, and corrective actions are recommended to strengthen compliance with ISO 13485 requirements.

Step 5: ISO 13485 Certification Audit

After the organization is ready for certification, SQS Global performs the certification audit, including documentation review and on-site assessment, to verify conformity with ISO 13485 requirements.

Step 6: Certification, Surveillance & Recertification

Upon successful completion of the certification audit, SQS Global issues the ISO 13485 certificate. We continue to support organizations through surveillance audits and recertification activities to help maintain certification validity and ongoing system effectiveness.

ISO 13485 Certification Registration Requirements

To apply for ISO 13485 certification, organizations only need to provide basic information and documentation related to their medical device manufacturing or distribution activities, including:

Business Registration Certificate
Product information, business scope and certification scope
Organizational structure and relevant personnel information
Existing procedures, documents or quality records (if available)

Based on the organization’s current situation, SQS Global will provide implementation guidance, support the development of ISO 13485 documentation, assist with certification preparation and accompany the organization throughout the certification process.