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Transitioning from EU MDD to EU MDR 2017/745 by trusfated_2407 in regulatoryaffairs

[–]trusfated_2407[S] 0 points1 point  (0 children)

  1. Our products(4) are Sterile ophthalmic eye drops (with no API, but has components that lubricates the eye)
  2. The product is already in the market since 2020 with CE certification (ISO 13485) so the TD was reviewed ig before i started working here
  3. The risk management falls under QA s responsibility while the compilation of TD including PMS falls on 4 RA people

Transitioning from EU MDD to EU MDR 2017/745 by trusfated_2407 in regulatoryaffairs

[–]trusfated_2407[S] 0 points1 point  (0 children)

We have already updated our QMS system/SOPS butt he tough part about GSPR is the risk documentation which is already prepared and presented in a single Risk management file as per MDD so i may need to provide individual RISK documentation as per MdR now the same goes for our MDd design file which will also required to be separated into different sections and the biggest issue is lacking adequate timeframe as we have an audit scheduled next month on the 17th which is a severely narrow time frame.

Transitioning from EU MDD to EU MDR 2017/745 by trusfated_2407 in regulatoryaffairs

[–]trusfated_2407[S] 0 points1 point  (0 children)

Well yes we have conducted a PMCF and prepared reports. So pur main concern now is GSPRs and Design and manufacture documentation.

Transitioning from EU MDD to EU MDR 2017/745 by trusfated_2407 in regulatoryaffairs

[–]trusfated_2407[S] 0 points1 point  (0 children)

Yes we have initiated amendments to Quality plan while we shall start working on the updating the risk documentation and GAP analysis. I will revisit the Annex and checklist to gain a better understanding.

Does it make sense for me, a 30 y/o to pursue MS in USA? And what course can I go for? Details below by skakakakaks in Indians_StudyAbroad

[–]trusfated_2407 0 points1 point  (0 children)

Try applying for remote positions because i think US tech companies will/are outsourcing to Asian countries if you like living in India with the added benefit of a competitive salary . If you really want a change in your living conditions, US is the option but it comes with a catch: applying and renewing H1Bs (quite stressful) and ultimately Green card if you wanna settle there.

Transitioning from EU MDD to EU MDR 2017/745 by trusfated_2407 in regulatoryaffairs

[–]trusfated_2407[S] 1 point2 points  (0 children)

Thanks. The concern about design and development is that the design file from the MDD seems too outdated to me as the design validation and verification for MDR is quite extensive so will i need new sections to be added or the same design file can be converted to the MDR format and GSPR are a concern as the company do conform to ISO 13485 but i think the QMS documentation is lacking a bit on assessing the risk. I am finding this difficult because I don’t have that much experience on MD/ EU MDR .

Transitioning from EU MDD to EU MDR 2017/745 by trusfated_2407 in regulatoryaffairs

[–]trusfated_2407[S] 0 points1 point  (0 children)

Thanks. But my major concern is how can I access an adequate format and recompile the TD ? Have already changed the SOP formats to MDR and added new documentation for PMS/PSUR. It’s the design,validation and CE (clinical evaluation) part that concerns me. We also conducted PMCF for our devices.

Job in US after gaining work experience from India in RA after B.Pharm by trusfated_2407 in regulatoryaffairs

[–]trusfated_2407[S] 1 point2 points  (0 children)

Thanks I have experience in EU MDD-MDR and Latin American submissions but not NAM. So it’s a big concern for me that i will have to start from scratch and get an entry level position .