ISO 13485 Certification is a parallel standard issued to create a QMS in the medical device industry in the European Union. The requirements of these two standards are identical, and the entirety of the ISO 13485:2016. However, EN ISO 13485 includes several invaluable tables that align the ISO 13485:2016 requirements to MDR 2017/745 and IVDR 2017/746. It is expected that a new version of EN ISO 13485 certification will be released soon.
ISO 13485 Certification
ISO 13485 Certification Process
ISO 13485 Certification is NOT mandatory for anyone who even applied for medical device product Certification. ISO 13485 Implementation is compulsory for CE Marking under MDR or IVDR. The following are the critical steps in ISO 13485 certification.
- Identification of activities and medical devices to be covered in the certification scope
- Identify the process owners
- Identify the scope exclusions
- Draft Quality Manual and define Quality Policy
- Identify the mandatory procedures and draft the policies with the help of process owners.
- Implement the procedures and create documentary evidence for each activity carried out
- Conduct Internal Audit and close all GAPS
- Apply with Certification Body (CB) and invite for an onsite audit
- Answer all queries / NC from CB
ISO 13485 Certification Consultants
ISO 13485 Certification Consultants work to provide solutions to the client’s changing business and regulatory needs (country-specific). The ISO consultants knowledge and experience are often required to become aligned with a specific industry of their choice and eventually achieve error-free compliance.
(BS) (EN) ISO 13485 certification specifies requirements for a quality management system where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
The requirements of ISO 13485:2016 apply to organizations regardless of their size and type, except where explicitly stated. Wherever requirements are specified as applying to medical devices, the conditions apply equally to associated services supplied by the organization.
ISO 13485 Consultants Roles and Responsibilities
ISO 13485 Certification Consultants play a crucial role in helping organizations comply with the ISO 13485 standard for medical device quality management systems.
- Compliance Assessment: ISO 13845 Consultants evaluate an organization’s existing processes and procedures against the requirements outlined in ISO 13485. They identify gaps and areas for improvement to achieve compliance.
- Gap Analysis: Consultants conduct a thorough analysis to identify areas where the organization’s current practices fall short of ISO 13485 requirements. They provide recommendations and strategies to bridge those gaps.
- Documentation Development: Consultants assist in developing and implementing necessary documentation, such as quality manuals, procedures, work instructions, and forms, aligned with the requirements of the standard.
- Process Improvement: Consultants help organizations streamline their processes and workflows to meet ISO 13485 requirements. They identify opportunities for efficiency gains, reduce waste, and enhance overall quality management.
- Training and Education: Consultants provide training and education sessions to familiarize the organization’s employees with ISO 13485 requirements, ensuring everyone understands their roles and responsibilities in maintaining compliance.
- Internal Audits: Consultants conduct internal audits to assess the organization’s adherence to ISO 13485. They evaluate the effectiveness of the implemented quality management system and identify areas for corrective actions and continuous improvement.
- Corrective Actions and Continuous Improvement: ISO 13845 Consultants guide organizations in implementing corrective actions based on audit findings and assist in establishing mechanisms for ongoing improvement to maintain compliance and enhance the effectiveness of the quality management system.
- Regulatory Compliance Guidance: ISO 13485 Consultants stay up to date with regulatory changes and provide guidance on compliance with relevant medical device regulations and standards beyond ISO 13485, helping organizations navigate the complex regulatory landscape.
Overall, Consultants work closely with organizations to ensure the implementation of a robust quality management system, adherence to ISO 13485 requirements, and continuous improvement of processes to achieve compliance and enhance the quality and safety of medical devices.
ISO 13485 Certification can help you comply with EU IVDR & MDR
ISO 13485 Consultants Fees
Drafting of Quality Manual, Mandatory Procedure and Important templets
20 Working Days
Process owner Interaction and Guidance via Skype / Zoom / or any other medium
|349 USD per hour||
Process owner Interaction and Guidance
849 GBP per Man-day
|Average 2 hours per mandatory procedures|
|Internal Audit||849 GBP per Man-day||
Two man-days are sufficient for small and medium-sized companies
IQA Training / ISO Awareness training
949 GBP per Man-day
1 to 2 man-days
Integrating EN / BS ISO 13485 Certification with 21 CFR 820
We work as regulatory advisors for the US Food and Drug Administration. Manufacturers may integrate both standards into a single documentation system with our help. Our ISO 13485 Consultants have worked on similar projects before and have dealt with FDA auditors. Remember, always approach ISO 13485 Consultants who are in the field of medical device regulatory compliance for your ISO 13485 Implementation.