ISO 13485 & EU MDR - Expert Advice Community

Internal audit ISO 13485

Hi does the internal audit checklist also cover the requirement for iso 9001? We got a non conformity for this.

Career in medical devices space

For someone interested in entering the medical devices space, can you advise on an approach to this side of the industry?
What certifications are needed? What career ladder is there? What paths are possible? Can this be self-taught? Can you share your experience?

Packaging for non sterile product

What is the requirements of managing a  flow of the process for non steriled category? we don't fall in the cleanroom criteria.we need just follow the controlled environment. Only problem is packaging outside the assembly line .so is it ok (or) will have to go for civil change. we primary packaging as polythin . we are mechanical ventilator manufacture with non sterile .

Verification Inspection Reports

We have been asked by the PRRC to manage Verification Inspection Reports for each batch release - said QA Manager could not release a batch if this VIR document is not  signed off by the PRRC. I have searched MDR and did not find this document above.
My question is if this VIR exists, if yes if it is compulsory. If not, in what way PRRC is involved in batch release.

Best practices in utilizing old clinical studies

What are the Best practices in utilizing old clinical studies for a product which is already on market for the last 15 years?

Članak 10. MDR-a

Zahvaljujem na zanimljivom predavanju.

Ako nije problem, zanima me tumačim li dobro Članak 10. MDR-a kad je u pitanju QMS i IMD. Razumijem li dobro da proizvođač ispitivanog MD, koji tek razvija svoj prvi proizvod i nema zaposlenike već samo otvorenu firmu s upravom, nije dužan uspostaviti QMS dok proizvod nije u fazi pripreme za certifikaciju?

Jasno mi je da sustav ne može funkcionirati bez zaposlenika, no on se ipak može smatrati proizvođačem IMD-a iako ima podugovorenu proizvodnju istog kod certificiranog proizvođača. Da li dobro tumačim?

Puno hvala i lijep pozdrav,

Quality Control Documentation

Can you please help me how to start to learn about Quality Control Documentation?

ISO 14001 communication procedure lacking in ISO 13485

In the iso 14001 EMS there is a section about communication within the company. However in the iso 13485  toolkit there is no such procedure or document. Why is this?. We have our audit on Monday, and one point within iso 13485 is about communication. How should I think here?

Enquiries on Project Plan and review

I have started to implement the SOPs and Appendices provided to me previously and requires clarification on one of the appendices, Project Plan and review.

May I know what do I have to fill in under the column for "inputs", "deliverables" and "resources"? Do you have some example to show us what kind of information do we have to fill in?

Amount of staff ISO 13485

We have seen a reduction in staff in company due to reduction in sales and we are wondering how that can affect our ability to hold and maintain iso 13485. Are there any fixed numbers of staff that one must have to obtain iso 13485 and if staff continues to reduce, what actions should we take. For instance we have our iso certification next week and if we are approved for the iso13485, what can happen afterwards if lets say people decide to leave the company? We are a total of 5 personell today, what would happen if we are only 2 or 3? Should this be risk assessed?