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What are the Benefits of a Formal Medical Device Management System?

1. A body of evidence demonstrating compliance with applicable legal and regulatory requirements. Under EU MDR and IVDR, a formidable mass of documentation can be required.
2. Management systems are designed to:
   • Get it right the first time,
   • Be consistent and reliable,
   • Seek out the root causes of problems,
   • Not to repeat mistakes.
3. All aspects of supply, installation, and maintenance throughout the product lifecycle are done in compliance with applicable regulations.
4. Organized management: An organization certified to the Standard is managed in a standard and structured way.
5. Clarity of Purpose: Staff know their responsibilities, authorities, and accountabilities.
6. Processes and procedures suited to the Mission and strategic objectives that you have set for the organization.
7. Internal audits to monitor compliance with requirements and highlight deficiencies.
8. Corrective actions to prevent the recurrence of errors – try to make mistakes only once, if at all.
9. An informed Board of Directors, knowing that the organization is focused on strategic objectives while satisfying compliance requirements and planning and acting to address future challenges.
10. Management satisfaction knowing that the organization is functioning in line with strategic objectives.
11. Reduce errors: Fewer costly errors, less rework, replacement of goods and/or services, and increased productivity.
12. Fewer customer complaints as fewer errors occur.
13. Better retention of customers: a consequence of reduced errors.
14. Management performance improved as less time is spent apologizing to customers and managing the unnecessary repetition of work.

What is ISO 13485 Certification?

An ISO 13485 Certificate is recognition from a Certification Body – CAB (usually an accredited Certification Body), or in relation to EU regulations, a Notified Body, that an organization has implemented and is maintaining a quality management system that meets the requirements of ISO 13485:2016.

Who needs ISO 13485 Certification?

Organizations globally, both in the public and private spheres and from every economic sector involved in providing medical device products and associated services, need to demonstrate compliance with ISO 13485.

Relevant organizations would include distributors and those trading in medical devices, and this can apply to any stage of the lifecycle. For more, see ISO 13485 Certification for the Medical Device Supply Chain.

What are the benefits of having ISO 13485 Certification?

1. Feedback: First and foremost, ISO 13485 Certification is about confirming compliance with regulation and then through Feedback (including PMS – Post Market Surveillance) that the device remains fit-for-purpose in fulfilling its specification and purpose and identifying opportunities for improvement.
2. Reputation: Be taken seriously as a prospective supplier, other than a manufacturer, as the holder of ISO 13485 Certification, based on the independent assessment of an accredited certification body.
3. Qualify for pre-tender and tender opportunities, especially for distributors to the public sector.
4. Status: On equal terms with the ‘big’ boys’ – the size of your organization won’t hold you back. And for newcomers, you demonstrate commitment to the medical device sector.
5. Risk management is implemented by manufacturers and others to ensure the safe and misuse of the device. Invariably, ISO 14971 is used here. Apart from this, a risk-based approach is applied to all processes.
6. Objectives and improvement obligations focus you on setting targets for improvement and then planning and implementing them in a timely manner.

How can you be sure that the ISO 13485 Certificate is legitimate and internationally-recognized?

CABs issue certificates to organizations after they have undergone an ISO Certification process. This process is based on a comprehensive two-stage audit (itself based on the auditing standard ISO 19011) that involves a documentation review and an independent on-site audit.

The CAB gathers and documents objective evidence of compliance with the requirements of ISO 13485. After the CAB has confirmed that all the requirements of the ISO 13485 Standard have been implemented and are being maintained, a Certificate is issued as is permission to use logos to publicize the fact.

What is ISO 13485 Training?

ISO 13485 involves training programs designed to equip auditors, lead implementers, quality managers, and other management system professionals with the necessary skills and knowledge to develop, implement, maintain, or audit Medical Device Management Systems and ensure their compliance with the requirements of ISO 13485.

Is this training mandatory?

Yes and No.

Management Representative or other professionals with day-to-day responsibility in maintaining an MDMS are not required to undergo ISO 13485 training. It is instead implied as already part of developing competence. It is not a specific stand-alone requirement.

That said, ISO 13485 training is strongly recommended as effective internal audits are essential to doing a professional job in maintaining your Medical Device Management System and preparing it for Certification Body audits.

How Can I Enroll in an ISO 13485 Training Course?

You can enroll in any of deGRANDSON’s online training courses by going to the product page of the course you want to enroll in. Once there, add the course to your cart and then proceed to checkout and payment.

Once you’ve paid for the course, you will be asked to provide the email address or addresses of the people who will be enrolling in the course. They will then receive an email providing the username and password they would need to access deGRANDSON’s Learning Management System where the training is delivered.

Please see this video to see a more visual demonstration of the enrollment process.