Connie Del Buono

On a mission to make Regulatory and Compliance easier for innovative and entrepreneurial medical technology companies.

[Connie Del Buono @Synoptyx]

@Mishi_2210 127

[Connie Del Buono @Synoptyx]

@ElonMuskNews47 Hope

[Connie Del Buono @Synoptyx]

Draft Act "Products with an aesthetic or non-medical purpose – safety requirements"
has Feedback period. 14 Jan. - 11 Feb. 2022
...ie cosmetic implants, dermal fillers, body sculpting eq., contact lenses, body hair removal & electrical brain stimulator
https://t.co/6DHLpLe3rf

[Medtech Insight, Citeline Commercial @Medtech_Insight]

GMed Designated Under EU IVD Regulation
https://t.co/g4T1XmF9iU

[Connie Del Buono @Synoptyx]

Join us at the RAPS workshop June 16 & 17 to ask all your IVDR questions!

[Connie Del Buono @Synoptyx]

Register at:

https://t.co/xo6cIcmnpy

[Connie Del Buono @Synoptyx]

Register at:

https://t.co/xo6cIcmnpy

[Connie Del Buono @Synoptyx]

Event Details https://t.co/OVn5tIUyCe

[Leo Eisner @EisnerSafety]

EUDAMED Actor Registration Module Goes Live as of 1 December 2020 - European Commission https://t.co/5n8lxVrvaN

[Connie Del Buono @Synoptyx]

HOW TO WORK WITH EMERGENCY RULES RELATING TO COVID 19? by @AxonLawyers #corona #covid19 https://t.co/XTmPLVbsCa via @SlideShare

[Connie Del Buono @Synoptyx]

MDR delay official as industry calls to push back IVDR https://t.co/MtA6iZiOPR

[Connie Del Buono @Synoptyx]

APRIL #MDR #MDCG Guidances, Timely on #ventilators +their accessories, clarified Art. 54(2)b devices exempt from pre-market clin. eval. consultation and Sufficient Clin Evidence-Legacy Devices, Clin Eval- Equivalence, PMCF Plan & Eval Report Template

https://t.co/JkxuvtCHeQ

[Regulatory Affairs Professionals Society @RAPSorg]

COVID-19 IVD quality problems drive EC guidelines | #Regulatory Focus https://t.co/JnS72XIHRV

[MedicalDevicesLegal @MedDevLegal]

New #MDCG guidance on temporary extraordinary measures related to medical device #NotifiedBody #audits during #COVID-19 quarantine orders and travel restrictions
#medicaldevices #medtech #notifiedbodies #MDR #IVDR #MDD #IVDD #AIMDD https://t.co/xkWBYBIuqo

[Connie Del Buono @Synoptyx]

Thank you for the added note that it’s becoming more frequent for the FDA to fault the firm when they do not include interim controls when a final corrective and preventive action cannot be implemented immediately.

[Redica Systems @RedicaSystems]

Enforcement last week included a collection of warning letters including three device warning letters and three drug GMP warning letters. And, warning letters to firms touting treatments for the coronavirus disease finally started appearing.
https://t.co/Yak58c57sH

[Connie Del Buono @Synoptyx]

Brexit is a fact - now deal with it https://t.co/yjXWxEFFv2 via @erikvollebregt

[MedicalDevicesLegal @MedDevLegal]

More on the #PRRC under new EU #medicaldevices regulations #MDR #IVDR https://t.co/tC98d7Da5f

[Connie Del Buono @Synoptyx]

The EU’s Medical Device Regulation (EU) 2017/745 – Are You Ready for Huge Sweeping Changes? https://t.co/jb5kYKYFox via @incompliancemag

[Connie Del Buono @Synoptyx]

Join me at the RAPS 2019 IVDR Pre-Conference Workshop on Sept. 21st in Philadelphia. Early registration til Friday 28 June 2019 https://t.co/Mj9YZKltRN

[Connie Del Buono @Synoptyx]

RAPS 2019 Sept. 21 workshop:Moving Beyond IVDR Req's to Fulfillment
How do you move beyond knowing what the IVDR requirements are to how to fulfill them? New concepts apply. ~90% of IVDs currently on EU market have not been scrutinized by a Notified Body, this is a new experience

[Connie Del Buono @Synoptyx]

Erik, thanks for keeping this up front for MD to see...
Bottleneck of bottlenecks for notified body capacity https://t.co/WPeNpX2ydo via @erikvollebregt