Moving from Medical Device Class I to Class II - Specification Designers

J

Jeff EORL

Good Day to all.

I have a small medical device company. We are currently specification designers of Class I devices. We are preparing to move in to Class II devices. I am up dating the QS to reflect this change.

I am a novice at this QS thing. I could use some help/feedback before I bring in any consultants $$$

Can anyone comment on the SOP's I have been working on thus far.

Complaint SOP, MDR SOP, CAPA SOP for starters. In progress is the Medical Device Recall, FA SOP's

Thank you so much for this forum your feedback and help are appreciated!!!

Jeff
 

Attachments

  • SOP000019 Medical Device Reporting.doc
    36 KB · Views: 588
  • medical device reporting tree.doc
    42 KB · Views: 357
  • SOP000013 Rev C Corrective and Preventive Action.doc
    149 KB · Views: 561
  • SOP000003 Rev E Complaint Handling.doc
    50 KB · Views: 648
  • FRM000013-01 Rev B Request for Corrective and Preventive Action.doc
    44 KB · Views: 306

yodon

Leader
Super Moderator
Without reading your SOPs yet, I'm curious as to why these needed updates? These should be pretty constant between class I & 2. I would think the focus area for such a change would be in design controls. I hope to get a chance to review the SOPs but wanted to bring this up.
 

Ronen E

Problem Solver
Moderator
Good Day to all.

I have a small medical device company. We are currently specification designers of Class I devices. We are preparing to move in to Class II devices. I am up dating the QS to reflect this change.

I am a novice at this QS thing. I could use some help/feedback before I bring in any consultants $$$

Can anyone comment on the SOP's I have been working on thus far.

Complaint SOP, MDR SOP, CAPA SOP for starters. In progress is the Medical Device Recall, FA SOP's

Thank you so much for this forum your feedback and help are appreciated!!!

Jeff

Hi,

Sorry, but I'm a bit short of time so can't review your documents at the moment. However, I agree with yodon that the major difference between a class 1 only manufacturer (including spec developers) and the rest are design controls (21 CFR part 820.30), unless of course if you were already within the group of class 1 devices requiring design controls anyway.

2 key statements reg. coverage of the QS system for spec. developers:

1. "Specification developers are subject to quality system requirements that apply to activities they conduct."

2. "Manufacturers should not generate and use procedures that are not needed."
 

Statistical Steven

Statistician
Leader
Super Moderator
I assume you or will have an Analysis of Data procedure. Important to trend complaints and CAPA data. Part of Management Review.
 
E

engr.post

Jeff, who would normally manage your quality system. What's been the ceo's involvement or direction over time for quality generally?

best
 
J

Jeff EORL

I believe that the MRD,CAPA, ect for a class II device as apposed to a class I exempt device added some complexity to our SOP that I had to up date. If not, what we had previously needed to be up dated.

I would appreciate your feedback if you get a chance. I really respect this forum and have learned a lot from it.
 
J

Jeff EORL

we design class I exempt devices, but have a quality system that has design controls to comply with class II devices. I think we were a bit light in the MDR CAPA and complaint SOP to be compliant with requirements so that is what I was trying to up date.

Would love to have your input though if you get a chance.

thanks
Jeff
 
J

Jeff EORL

Our CEO is involved daily in the quality and the systems we have in place. currently we are looking for someone to manage the system on a day to day basis. I am making the needed changes currently.

Thanks
Jeff
 
J

Jeff EORL

Steven

Thanks for the thought I will look to add this to our SOP's. Any suggestions on the procedure?

Thanks
Jeff
 

Statistical Steven

Statistician
Leader
Super Moderator
I typically tell clients to think of how data is presented and analyzed for management review. This usually includes the bar chart, pareto chart, cause and effect, etc. Look for the 7 quality tools and the 7 new quality tools.
 
Top Bottom