ISO 13485 Certification Support for Medical Device Companies

ISO 13485 CONSULTING & CERTIFICATION SUPPORT

✔️ A clear implementation roadmap focused on the key requirements of ISO 13485, helping your organization prepare for certification.

✔️ Processes, templates, and documentation developed in accordance with ISO 13485:2016 and aligned with the audit practices of accredited certification bodies.

✔️ Internal audits, documentation reviews, and corrective action guidance to support certification readiness.

✔️ Dedicated expert support throughout the certification preparation process.

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ISO 13485 CONSULTING & CERTIFICATION SUPPORT

✔️ A clear implementation roadmap focused on the key requirements of ISO 13485, helping your organization prepare for certification.

✔️ Processes, templates, and documentation developed in accordance with ISO 13485:2016 and aligned with the audit practices of accredited certification bodies.

✔️ Internal audits, documentation reviews, and corrective action guidance to support certification readiness.

✔️ Dedicated expert support throughout the certification preparation process.

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 Consulting & Certification Support for Medical Device Companies

SQS Global provides ISO 13485:2016 consulting, training, Quality Management System (QMS) implementation, internal audit, and certification support for medical device companies. With a structured implementation roadmap and documentation aligned with the standard’s requirements, organizations can reduce implementation time and improve their readiness for certification by an accredited certification body.

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

Helping organizations complete documentation, address nonconformities, and prepare confidently for the certification audit with accredited certification bodies.

Register for an ISO 13485 Consultation at SQS Global

Exclusive benefits when you register for an ISO 13485 consultation with SQS Global:

✔️ Free initial assessment of your current system and readiness

✔️ A customized ISO 13485 implementation roadmap based on your organization’s size and business activities

✔️ Guidance on regulatory requirements for medical device manufacturing

✔️ A complimentary ISO 13485 readiness checklist

✔️ Free document templates and reference materials for QMS implementation

✔️ Expert support throughout the certification preparation process

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ISO 13485 QMS Certification Support Service Information

Due to the nature of the medical device industry, ISO 13485 certification audits are conducted on-site at the organization’s manufacturing facility or operational location. Following an initial assessment, our experts provide guidance on the standard’s requirements, assist with documentation, and develop an implementation roadmap tailored to your operations.

Estimated implementation time and certification support costs:

Service Fee: Depends on the organization’s size, certification scope, and the current status of the Quality Management System (QMS).
Implementation Time: Typically 30–90 days, depending on the organization’s level of readiness.

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 Support Process at SQS Global

SQS Global follows a six-step consulting and certification support process led by experienced medical device specialists. We help organizations establish an ISO 13485 Quality Management System (QMS), prepare the required documentation, and confidently achieve certification readiness.

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

Once your organization has completed the implementation and addressed any identified nonconformities, SQS Global reviews the documentation, assesses certification readiness, and provides support throughout the certification process with an accredited certification body, helping improve the likelihood of achieving certification on the first audit.

Step 6: Maintain & Continually Improve the QMS

After your organization achieves ISO 13485 certification, SQS Global continues to support the maintenance and continual improvement of your Quality Management System (QMS) through periodic internal audits, updates on standard requirements, and preparation for surveillance and recertification audits.

Requirements for ISO 13485 Certification Implementation

To begin the ISO 13485 certification process, your organization only needs to provide basic information and documents related to its medical device operations, including:

Business Registration Certificate
Product information, business activities, and certification scope
Organizational chart and relevant personnel information
Existing procedures, documented information, or records (if available)

Based on your organization’s current situation, SQS Global will assess your level of compliance, recommend an implementation roadmap, develop the required management system documentation, and help you prepare for the certification audit in accordance with your organization’s size and operational needs.