Medical Device Testing Based in Manchester? Consultant to open Technical File

M

masoud

#1
Hi,

I am looking for a consultant based in Manchester to open technical file and testing for medical device (dental implant), Please respond to me as soon as possible if there is any here.
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Medical Device Testing Based in Mancheser?

Good morning and welcome to the Cove!

Manchester, UK? Or NH, USA? Or someplace different? Please give us some more details so we can better serve you.
 

Stijloor

Staff member
Super Moderator
#3
Re: Medical Device Testing Based in Mancheser?

Good morning and welcome to the Cove!

Manchester, UK? Or NH, USA? Or someplace different? Please give us some more details so we can better serve you.
He lives in the "European Union", so Manchester, UK may be the location.
We'll find out soon....

Stijloor.
 

rob73

looking for answers
#4
Masoud
Attach is a list of notiifed bodies for CE certification, its for the whole EU but a quick search will show the UK ones. AMTAC show up in Manchester but I know they have been taken over by INTERTEK so the office may have moved.
Good luck
Rob
 

Attachments

S

SteveK

#5
Hi Masoud,

Do you want somebody to look at your technical file or do you want somebody to prepare one (including testing) – not really clear from your post? Although I do not have a copy, the harmonised standard for dental implants is BS EN 1642:2004. This is what it should comply with. As indicated there are various NBs in the UK who will assist – FYI Intertek took over Amtac, but still use their registration number separately from Intertek (www.intertek-acsl.com).

Steve
 
Thread starter Similar threads Forum Replies Date
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 11
K Release testing for Combination Drug-Medical Device Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
S Medical Device Endotoxin Testing for ANSI/AAMI ST72:2011/2016 Other Medical Device Related Standards 1
M Medical Device News Health Canada update - Applications for Medical Device Investigational Testing Authorizations Canada Medical Device Regulations 0
S Routine Testing for Class I Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 24
K Biocompatibility Testing - Component Level or Assembled Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 7
M Investigational Testing - Does the Medical Device have to be "sold"? Canada Medical Device Regulations 7
M Testing a Low Current (Battery) DC Medical Device Other Medical Device Related Standards 4
N Reliability Testing of a Single-Use (Disposable) Medical Device Reliability Analysis - Predictions, Testing and Standards 4
J IEC 60601 Medical Device Testing House Costs IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
N Class 2 Medical Device Use Life Testing Reliability Analysis - Predictions, Testing and Standards 1
ScottK Importing medical device for use in fit testing of packaging Other US Medical Device Regulations 3
S Sample performance testing for a software-only medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M EMC Testing for a US-only, Home-Based Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Medical Device Testing for Airport Security US Food and Drug Administration (FDA) 5
R Medical Device Software - Final Field Testing Best Practices IEC 62304 - Medical Device Software Life Cycle Processes 5
N Critical Analysis of Medical Device Bench Testing data ISO 13485:2016 - Medical Device Quality Management Systems 6
A Beta Testing FDA Regulated Medical Device Software vs. Nonconforming product? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
F Wireless Dongle - Include in Medical Device Testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
L Medical Device Stability Testing Requirements EU Medical Device Regulations 1
J EMC Testing for Medical Device with Solenoid Valves IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
G Margin of Safety for Medical Device Fatigue Testing Reliability Analysis - Predictions, Testing and Standards 5
D Testing to determine Life Cycle of a Medical Device Reliability Analysis - Predictions, Testing and Standards 7
J Biological Evaluation requirements per ISO 10993 - Medical Device Testing ISO 13485:2016 - Medical Device Quality Management Systems 2
K High Risk Medical Device Type Testing (China Requirements) China Medical Device Regulations 5
K High Risk Medical Device Type Testing in Korea (Requirements) Other Medical Device Regulations World-Wide 5
A Taguchi Inner and Outer Array Design for Medical Device Testing Quality Tools, Improvement and Analysis 1
M Brazilian Requirements for Medical Device Production Testing to IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Separate Medical Device 12V Power Source - What inspection and testing is required? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Sam Lazzara Seeking Medical Device Luer Fitting Testing Laboratory Service Other Medical Device Related Standards 5
E Reference Standard for Shelf Life Testing of Packaging for Sterilized Medical Device Other US Medical Device Regulations 3
E IEC/EN 60601 Testing and CE Marking for a Non Medical Device CE Marking (Conformité Européene) / CB Scheme 11
A Medical Device Design Verification Testing - Is ISO 62366:2008 what I'm looking for? IEC 62366 - Medical Device Usability Engineering 16
M Shelf Life Testing of a Sterile Medical Device Other Medical Device and Orthopedic Related Topics 40
S Sterile Product Ship Testing (Medical Device Packaging) EU Medical Device Regulations 3
A Medical Device (Gloves) Stability (Aging) testing and Shelf Life Other Medical Device and Orthopedic Related Topics 15
Y Acceptable Fatigue Safety Factor for Testing Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 2
F Medical Device Stability Testing Other Medical Device and Orthopedic Related Topics 9
M Types of Medical Device Cytotoxicity Testing - ISO 10993-5 Other Medical Device Related Standards 4
M Medical Device Biocompatibility Testing - End Product or Components - ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 22
M V&V (Verification and Validation) Medical Device Unit Testing ISO 13485:2016 - Medical Device Quality Management Systems 4
L How to prepare preclinical physical testing? Medical device license Other Medical Device and Orthopedic Related Topics 5
S Relevant Packaging Standards for Medical Device Package testing ISO 13485:2016 - Medical Device Quality Management Systems 10
J Medical Device QC Testing - Number of Samples as Batch Size Increases ISO 13485:2016 - Medical Device Quality Management Systems 13
J Endotoxin testing - Raw materials and components of a Class III medical device ISO 13485:2016 - Medical Device Quality Management Systems 6
amjadrana Medical Device EMC requirements - Canada - Testing to FCC part 18, EN 55011, EN 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4

Similar threads

Top Bottom