ISO 13485 for Class 1 Medical Device

[Angela O’Reilly]

Are the certification requirements the same for Class 1 and Class 2 medical devices? In other words is the same level of system robustness, including records the same.
To achieve certification is there a requirement to complete a full generation of all records retrospectively for every product?
I want to map out resource requirements

 

[DannyK]

Please specify the jurisdiction that you want to distribute products so that we could provide you with a specific answer.

 

[Angela O’Reilly]

Europe and USA

 

[yodon]

Short answer is no, the burden for Class I devices is (generally) lower. For example, in the US, Class I devices *may* be exempt from design controls. You'll have to consider specifics, though, for a precise answer.

To achieve certification is there a requirement to complete a full generation of all records retrospectively for every product?

Not completely sure I understand what you're asking here. When there is a regulatory requirement you need to meet, you do have to provide evidence of meeting it. Generally, this is done at the product level; e.g., Verification and Validation records for the product, not for every device built of that product. There are records required from production so in that respect, there would be records for every item built. Maybe clarify the question?

 

[Azhar Anwar]

Are the certification requirements the same for Class 1 and Class 2 medical devices? In other words is the same level of system robustness, including records the same.
To achieve certification is there a requirement to complete a full generation of all records retrospectively for every product?
I want to map out resource requirements

Are you referring to ISO 13485 QMS certificate? Or CE CERTICATE so on and so forth?
your question is not clear enough.

 

[Yasir]

Certification to the standard requires an organization’s quality management system to pass a third-party Medical Device Single Audit Program, or “MDSAP” Audit . Learn about the standard. Perform Gap analysis of your current QMS in line of the ISO13485. Then create your project plan and trained your staff about the standards and check regularly the results. Design and document your ISO 13485 Quality Manual and Procedures. The biggest portion of the project is looking at your current processes and redesigning them to address all of the requirements of the standard. Once you have modified or developed processes to meet the standard, you will need to control those processes.

Once your system is developed and documented, employees will follow the procedures, collect records, and make improvements to the system. For approximately three months or more, your organization will run the QMS, collecting records. To achieve registration, you will need to select a Registrar who will perform a Registration Audit.

 

[Angela O’Reilly]

Thanks for the reply. Yes we are taking this approach. I’m struggling with the level of records/proof we need for certification. For example.. prior to the audit, would you expect to see a record of competency for all employees based on qualifications and experience along with a training plan linked to all relevant procedures and the associated records for training to every relevant document. This would apply to all employees involved in activities throughout the lifecycle with their competency assessment and training proportionate to the risk of their tasks? I am trying to get an idea of the work involved to fill the gaps. Another example... would you expect a retrospective review of all complaints with a documented assessment to determine if the risk file should be updated or a design update. Thank you

 

[RAQA Support]

Thanks for the reply. Yes we are taking this approach. I’m struggling with the level of records/proof we need for certification. For example.. prior to the audit, would you expect to see a record of competency for all employees based on qualifications and experience along with a training plan linked to all relevant procedures and the associated records for training to every relevant document. This would apply to all employees involved in activities throughout the lifecycle with their competency assessment and training proportionate to the risk of their tasks? I am trying to get an idea of the work involved to fill the gaps. Another example... would you expect a retrospective review of all complaints with a documented assessment to determine if the risk file should be updated or a design update. Thank you

You seem to have two main questions here:
1. Yes the training files need to be as thorough as you are stating. Training files are a common audit finding so do not be afraid to make them thorough when setting them up.
2. A retrospective review would not be expected. If you have any open items, those would need to be captured in the new system. And I would recommend if you have any high trending complaints to mention it in your first management review meeting. This will capture the past major problems without dragging all the previous documentation into the process.