SBS - The Best Value in QMS software

Informational Medtech Europe – Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR)

Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Informational Medtech Europe presentation – – Industry Perspective on the Implementation Status of the MDR/IVDR Medical Device and FDA Regulations and Standards News 0
M Informational Medtech Europe guidance – Use of Symbols to Indicate Compliance with the MDR Medical Device and FDA Regulations and Standards News 5
M Medical Device News MedTech Europe Statement on the Implant Files Medical Device and FDA Regulations and Standards News 0
M Medical Device News MedTech Europe - European Parliament further clarifies Commission proposal on HTA for medical technologies EU Medical Device Regulations 0
U Examples of Quality Objectives for a Medtech start up ISO 13485:2016 - Medical Device Quality Management Systems 4
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
M Informational From the Implant Files – French commission calls for massive medtech regulation overhaul Medical Device and FDA Regulations and Standards News 1
L Medtech regulation under scrutiny Other Medical Device Regulations World-Wide 1
Q How do you find best local distributors (UK/Europe)? Other Medical Device and Orthopedic Related Topics 0
R Compatibility studies for Combination Products - Europe Medical Device and FDA Regulations and Standards News 2
R Advice needed: Shall I report my not complying company to NB / competent Authority (Europe) EU Medical Device Regulations 6
M Europe GMP medical devices - Combination products - Ancillary medicinal substance CE Marking (Conformité Européene) / CB Scheme 4
N Importer of record - Europe EU Medical Device Regulations 0
A Donating sterilizing gel - Is it legal in Europe? EU Medical Device Regulations 1
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
E Machines in Europe not in compliance with the EC directive CE Marking (Conformité Européene) / CB Scheme 0
M One clinical design: Russia and Europe Other Medical Device and Orthopedic Related Topics 0
S Differences in CB expectations between the US and Europe Registrars and Notified Bodies 3
K Is Compliance Testing of IEC 60601-2-63 mandatory for Europe - Dental X-Ray machine CE Marking (Conformité Européene) / CB Scheme 3
M Informational EC – Guide for referencing standards in public procurement in Europe (JIS Action 11) Medical Device and FDA Regulations and Standards News 0
M RFID (Radio Frequency Identification) Registration in Europe and in MENA countries EU Medical Device Regulations 1
I Where to submit Adverse Events Reports in Europe EU Medical Device Regulations 7
K CE Mark in Material Testing Machines sold to Europe from the US CE Marking (Conformité Européene) / CB Scheme 3
C Exporting Adult Products from Europe to the United States 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Training courses for improving 'Coaching and Mentoring skills' within Europe Training - Internal, External, Online and Distance Learning 1
A US patient gets Medical Device in Europe and needs spare parts 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Need of EU representative if CE marked Med Device not marketed in Europe EU Medical Device Regulations 8
R Is there a mandatory medical device warehouse standard for europe? EU Medical Device Regulations 3
M CE Mark outside of Europe - Implications EU Medical Device Regulations 4
S Is Combination Product regulation available for Europe? EU Medical Device Regulations 2
M API Q1 Validation in Europe Oil and Gas Industry Standards and Regulations 8
T Testing Laboratories in Europe to IEC/EN 60601-2-47 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
C Selling of Research products in Europe EU Medical Device Regulations 9
D Use By and Expiration Date for a Class 3 Medical Device in Europe CE Marking (Conformité Européene) / CB Scheme 3
J Lean Transformation Project - Distribution centre in Europe Lean in Manufacturing and Service Industries 1
I Quality and Operational Excellence Training Institutes in Europe Training - Internal, External, Online and Distance Learning 1
M MDD Europe: Use EN ISO 14971:2012 or ISO 14971:2007 Quality Manager and Management Related Issues 9
S What are export requirements for Class I/II Medical Devices in Europe? ISO 13485:2016 - Medical Device Quality Management Systems 2
N Which regulations apply to Medical Stand Alone Software in Europe? ISO 13485:2016 - Medical Device Quality Management Systems 3
K Medical Device Identification Europe FDA CMDR Other ISO and International Standards and European Regulations 7
S QMS to demonstrate Compliance to Canada, Europe and Japan Other Medical Device Regulations World-Wide 7
A CE Certificate is valid until 3.12.2013 - Can I still sell the products in Europe? EU Medical Device Regulations 10
T CE Marking - Exporting replicas (Airsoft) to Europe CE Marking (Conformité Européene) / CB Scheme 1
G Can a Distributer in USA sell a medical device (CE marked) to Europe? CE Marking (Conformité Européene) / CB Scheme 2
J Shipping Liquids (Small Bottles of Ultrasound Gel) to Europe EU Medical Device Regulations 4
S GMP Comparative Information for Canada, US and Europe Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
M Proposal for revision of the Medical Devices Directives in Europe EU Medical Device Regulations 10
Sam Lazzara Updated Europe Harmonised Standards Lists (2012-08-30) EU Medical Device Regulations 3
N Europe import Regulations? Customers are requesting us to sign OEM/ODM Agreements EU Medical Device Regulations 7
P Testing a US device in Europe to prove Equivalence in a ?head-to-head? Study EU Medical Device Regulations 6

Similar threads

Top Bottom