Evidence of EUDAMED Registration

sallyann

Starting to get Involved
#1
Can I ask a question, we have been requested by external audit to provide our Eudamed Registration as evidence, what am I showing them, we only received an email with our SRN, anyone receive anything different?
 
Elsmar Forum Sponsor

sallyann

Starting to get Involved
#3
Thank you, I have done just that. Couldn't think of any other way to to demonstrate this. Haven't heard anything back as yet to suggest that this is not acceptable, so fingers crossed.
 
Thread starter Similar threads Forum Replies Date
R Evidence of compliance with Directive 2013/59/Euratom EU Medical Device Regulations 3
Q Documented Evidence of Training ISO 13485: 2016 ISO 13485:2016 - Medical Device Quality Management Systems 33
Ashland78 Need to show evidence in accordance with QR-11012 and SPB-00001-09 Customer and Company Specific Requirements 5
GStough Objective Evidence - Are Interviews Still Considered as Objective Evidence? General Auditing Discussions 15
I Software (SaMD) mobile application verification testing: objective evidence Medical Information Technology, Medical Software and Health Informatics 2
D What evidence do I need to supply as a remote location in relation to manufacturing sites? IATF 16949 - Automotive Quality Systems Standard 14
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Where to draw the line for "sufficient evidence" to verify safety/performance of a device? CE Marking (Conformité Européene) / CB Scheme 2
D Device functionality over service life - Objective evidence required? Design and Development of Products and Processes 10
C MDCG 2020-06 Clinical evidence legacy devices EU Medical Device Regulations 3
Mr Roo ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
M Informational Critical Thinking and the Process of Evidence-Based Practice Medical Device and FDA Regulations and Standards News 0
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
M Informational US FDA paper – Epidemiological Evidence on the Adverse Health Effects Reports in Relation to Mercury from Dental Amalgam: Systematic Literature Review Medical Device and FDA Regulations and Standards News 0
S Level of Clinical Evidence - MDR EU Medical Device Regulations 3
qualprod Evidence of a talk or phone call in approvals? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H Clinical evidence for Class II medical devices in EU and US EU Medical Device Regulations 6
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 8
N Best practices for capturing audit objective evidence in a practical manner? Internal Auditing 3
M Informational Health Canada – Guidance Document: Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing Medical Device and FDA Regulations and Standards News 0
R Timeframe for IATF 16949 certification to accumulate evidence of conformance of systems? IATF 16949 - Automotive Quality Systems Standard 2
M Informational TGA – Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices Medical Device and FDA Regulations and Standards News 0
E ISO 9001:2015 Clause 10.2.2 - Evidence of all nonconformities and actions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R 8.1.3 Management of change - Evidence of HIRA and related things Occupational Health & Safety Management Standards 3
Q Evidence of precautions (clinical evaluation report, risk management report) EU Medical Device Regulations 6
S Ways to demonstrate objective evidence that employee is trained and competent ISO 13485:2016 - Medical Device Quality Management Systems 28
mikinnear Evidence - Class IIb Disinfectant Sanitiser EU Medical Device Regulations 2
G FAI Objective Evidence AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Interested parties requirements - Evidence of control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Is evidence of second party audits required for every supplier? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J MDR and Creative Clinical Evidence Other ISO and International Standards and European Regulations 2
B IATF 16949 Cl. 9.2.2.1 - Internal audit program - Types of evidence Internal Auditing 1
E IATF 16949 Cl. 7.1.5.1 - Documented information as evidence of fitness for purpose IATF 16949 - Automotive Quality Systems Standard 3
Q How to provide evidence of Strategic Direction (Easy) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B IATF 16949 Cl. 7.1.6 - Organizational Knowledge - What evidence to have? IATF 16949 - Automotive Quality Systems Standard 1
D No evidence of certain processes on our scope being audited at our remote location IATF 16949 - Automotive Quality Systems Standard 4
R CAPA Verification - ISO 13485:2016 Requirements and Objective Evidence ISO 13485:2016 - Medical Device Quality Management Systems 2
R What kind of Objective Evidence - AS9100 Cl. 7.1.6 - Organizational Knowledge AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Informational Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 82
O ISO 9001:2015 4.4.1 - Providing Evidence of QMS Processes "Shalls" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Type of evidence for Mandatory procedures 4.4.2 A ad 8.5.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Clinical Evidence - Clinical Evaluation Report for Class I medical devices EU Medical Device Regulations 1
L AIs the R&R study a training evidence considered ? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
R What objective evidence can/can't be supplied during a customer audit? General Auditing Discussions 3
W Evidence for Review of Requirements - AS9100 Clause 7.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Audit Ethics and Practices regarding Evidence Internal Auditing 18
S Evidence of Competence, Training and Awareness Training - Internal, External, Online and Distance Learning 5
S Design and Development Document evidence for Engineering Consultant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Chennaiite Audit Objective Evidence - the holy **** Imported Legacy Blogs 1
J Evidence of ISO Training for all Employees Training - Internal, External, Online and Distance Learning 27

Similar threads

Top Bottom