ISO Medical Device Registration

Navigating the regulatory landscape for medical device registration can be complex and challenging. Our ISO Medical Device Registration services are designed to simplify this process, ensuring that your products meet international standards and gain swift market access. We provide expert guidance and support to help you achieve compliance with ISO standards and regulatory requirements, enhancing the quality and safety of your medical devices.

Why ISO certification matters

ISO (International Organization for Standardization) certification is recognized globally as a benchmark of quality and safety. For medical devices, ISO 13485 is the key standard, specifying requirements for a comprehensive quality management system. Certification to ISO 13485 demonstrates that your organization is committed to maintaining the highest standards of quality, ensuring the safety and efficacy of your medical devices.

Our ISO certification services

Gap Analysis and Assessment

• A comprehensive evaluation of your current processes and documentation against ISO 13485 requirements.
• Identification of gaps and areas for improvement.
• Detailed report and action plan to address deficiencies.

Quality Management System (QMS) Implementation

• Design and implementation of a robust QMS tailored to your organization's needs.
• Documentation development, including quality manuals, procedures, and work instructions.
• Employee training on QMS processes and ISO 13485 requirements.

Internal Audits

• Conducting thorough internal audits to ensure ongoing compliance with ISO 13485.
• Preparation for external audits by certification bodies.
• Corrective and preventive action (CAPA) management.

Regulatory Compliance Support

• Assistance with regulatory submissions and documentation for global markets.
• Guidance on compliance with MDR (EU Medical Device Regulation) and FDA requirements.
• Support in achieving CE marking and other regional certifications.

Certification Readiness and Support

• Liaison with certification bodies throughout the registration process.
• Support during on-site audits and inspections.
• Post-certification maintenance and continual improvement services.

Industries we serve

We support a wide range of industries within the medical device sector, including but not limited to:

a. Diagnostic devices

b. Surgical instruments

c. Implantable devices

d. Dental products

e. Laboratory equipment

f. Rehabiptation and assistive devices

Benefits of partnering with us

Expertise: Our team comprises experienced professionals with in-depth knowledge of ISO standards and regulatory requirements.

Customized Solutions: We provide tailored solutions to meet the unique needs of your organization and products.

Global Reach: Our services are designed to help you navigate regulatory requirements in various markets worldwide.

Efficiency: We streamline the certification process, reducing time-to-market and ensuring that your products comply with the highest standards.

Our service process

1. Initial Consultation: We begin with a detailed consultation to understand your needs and objectives.
2. Planning and Strategy: Development of a customized plan to achieve ISO 13485 certification and regulatory compliance.
3. Implementation: Execution of the plan, including QMS implementation, documentation, and training.
4. Audit and Review: Conducting internal audits and preparing for external audits by certification bodies.
5. Certification and Beyond: Supporting you through the certification process and providing ongoing support for continual improvement.

Ready to achieve ISO 13485 certification and ensure compliance for your medical devices? Contact us today to learn more about our services and how we can assist you in achieving your regulatory and quality goals.