SBS - The best value in QMS software

Informational UK – Brexit operational readiness guidance for the health and care system in England

Elsmar Forum Sponsor
#2
Hello Marcelo, long time no see! I hope you're doing well.

We're in a mess in the UK and EU, regardless of Brexit.

We have too much misinformation spilling form the top and most people just go with the flow.

I was at MedTech UK 2018 where our CA was promoting contact lenses as cosmetics.
I queried it and was told I was incorrect even though there had already been a court ruling in the European Court of Justice to clarify this for the CAs.

At IRIC May 2018 our CA was promoting blood and blood products as medical devices!

When NBs were under performing, the EC published a recommendation for NBs.
NBs and Team NB told industry these were all new requirements, when most had existed since 1993.

I wrote to Team NB and queried this. They insisted the recommendation was a new requirement!

I recently had a new 'EU Medical Devices Expert' tell me to put a WARNING on a device rather than a CAUTION.
I explained to her the difference, but she would not accept it.
She said 'there is no definition for WARNING?CAUTION and they are exactly the same.

I responded with FDA definitions, 60601 etc but this 'Expert' was a newly qualified medical doctor and she refused to accept my knowledge and 19 years experience.

So we're in trouble here and nobody is listening. Not even the CAs years ago when I warned them we would have a situation like we have today with toxic implants.
 
Thread starter Similar threads Forum Replies Date
dinaroxentool Selling a product in Both UK and EU after Brexit UK Medical Device Regulations 5
dgrainger Informational MHRA - Regulating medical devices in the UK - Post Brexit - 2021-02 UK Medical Device Regulations 0
T Brexit Transition Arrangements & Import into the EU EU Medical Device Regulations 3
E Brexit UK MDR brexit out of sync with EU MDR deadline? UK Medical Device Regulations 4
M Status of Medical Device Regulations in UK Post-Brexit Other Medical Device Regulations World-Wide 10
M Informational Update from GOV.UK – Regulating medical devices in the event of a no-deal Brexit – UK Responsible Person Medical Device and FDA Regulations and Standards News 0
M Informational HPRA Brexit Preparedness Checklist Medical Device and FDA Regulations and Standards News 2
M Informational From RAPS – Prep for Brexit: UK Seeks £25M Freight Service to Deliver Medicines, Devices Medical Device and FDA Regulations and Standards News 0
DMLqms Exporting into the EU from UK after Brexit EU Medical Device Regulations 3
M Informational TGA – Brexit – Implications for therapeutic goods in Australia Medical Device and FDA Regulations and Standards News 0
JoshuaFroud CE Marking and Brexit - Product shipped to a distributor prior to the March deadline EU Medical Device Regulations 2
M CE mark validity after Brexit, 29th March '19 EU Medical Device Regulations 6
M Informational Design for new product safety marking for the no-deal Brexit scenario Medical Device and FDA Regulations and Standards News 1
M Pharmaceuticals News UK – Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal Medical Device and FDA Regulations and Standards News 0
M Medical Device News Letter to the health and care sector: update on preparations for a potential no-deal Brexit Medical Device and FDA Regulations and Standards News 0
M Medical Device News Brexit - Withdrawal Agreement and Political Declaration laid before Parliament following political agreement. EU Medical Device Regulations 4
S How to Define Importers under EU MDR / Brexit EU Medical Device Regulations 3
F BREXIT - What/How are You and Your Business Preparing for It? EU Medical Device Regulations 20
R Brexit - European Commission - The impact of the Brexit per March 29, 2019 EU Medical Device Regulations 3
H Operational planning and product and service provision when things happen so fast ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Operational (free) simulation games for manufacturing and quality Lean in Manufacturing and Service Industries 5
Richard Regalado Top 10 operational risks of 2019 for business continuity planning Business Continuity & Resiliency Planning (BCRP) 6
I ISO 22000:2018 - Operational Prerequisite Program Examples Food Safety - ISO 22000, HACCP (21 CFR 120) 2
D Determining of sample size for 'Operational Qualification' AQL - Acceptable Quality Level 5
C AS9100 Rev D 8.1.1 & APQP - Operational risk management process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Z Operational Qualification for Injection Molding Supplier Quality Assurance and other Supplier Issues 6
L OpEx (Operational Excellence) Documents in QMS? Document Control Systems, Procedures, Forms and Templates 0
O Air Flow - Which is the operational difference between LAF (vertical and horizontal) and RLAF? Manufacturing and Related Processes 2
T Operational setup of how FIFO / Process Map on Lithium Batteries is done Manufacturing and Related Processes 1
C AS9100D, Clause 8.1 - Operational Planning and Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
J Installation Qualification (IQ) and Operational Qualification (OQ) for Laser Marking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Management control Procedures & Operational Control Procedures ISO 14001:2015 Specific Discussions 1
R AS9100D Cl. 8.4.2 - Identify Raw Material as a Significant Operational Risk AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
L Heated Sealed Packages - Sample Size for OQ (Operational Qualification) and PQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
A Quality Department - Operational Framework Service Industry Specific Topics 2
A Operational Procedure for an IT Service Industry Quality Department Service Industry Specific Topics 1
M Integrated Phased Processes - AS9100D cl. 8.1 Operational Planning - Clarification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A IT Managed Services Company Quality Department - Operational Document ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G How have you addressed Cl 4.4.6 Operational Control ISO 14001:2015 Specific Discussions 4
E Operational Qualification of a Drug Box Coding Device in Production Other Medical Device and Orthopedic Related Topics 1
J OQ (Operational Qualification) for Liquid-Water Isotope Analyser Other Medical Device and Orthopedic Related Topics 2
B Usage of Parts from OQ (Operational Qualification) Mold Validation ISO 13485:2016 - Medical Device Quality Management Systems 4
B OQ (Operational Qualification) of a Freeze Dryer Qualification and Validation (including 21 CFR Part 11) 2
I Quality and Operational Excellence Training Institutes in Europe Training - Internal, External, Online and Distance Learning 1
W ISO 14644 Cleanroom Validation - "Operational" Other Medical Device Related Standards 3
M Quality Manual - ISO 17025 required Mandatory and Operational Procedures ISO 17025 related Discussions 7
S Barcode Scanner IOPQ (Installation/Operational/Performance Qualification) Requirement Qualification and Validation (including 21 CFR Part 11) 9
J OHSAS 18001 Clause 4.4.6 Operational Control Example Procedure Occupational Health & Safety Management Standards 9
M Determining Sample Size needed for Operational Qualification (OQ) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 24
G Evaluation of Training for Operational Staff Training - Internal, External, Online and Distance Learning 8

Similar threads

Top Bottom