On-demand EU MDR Compliance toolkit with online training courses, templates & document management system

#1
Welcome to EnableCE - training courses to give you confidence and clarity when driving your EU MDR strategy.

Whether you are starting your journey to medical device regulatory compliance or have existing experience in this field, our range of resources cover a wide range of topics allowing you to pick and choose what you need. Our training courses are made up of on-demand videos and supporting documents. We cover areas such as Post-market Surveillance, Quality Management, Clinical Evaluation, Risk Management and more.

Gain confidence, reassurance & control over your EU MDR strategy. Do it once and do it right with our training courses, fill-in-yourself templates and document management solutions.

 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
I Can I Calibrate On Demand? General Measurement Device and Calibration Topics 9
W Tying the need for Demand Planning to a section of AS9100/9110 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Sidney Vianna Interesting Discussion World wide energy demand will peak in the early 2030's Sustainability, Green Initiatives and Ecology 0
Marc Definition PFD - Probability of failure on demand Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
R Are ISO 9001 Lead Auditors in demand? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Marc Business These Days - Maker's Mark waters down bourbon to meet demand Coffee Break and Water Cooler Discussions 11
G Supplier Demand Form Document Control Systems, Procedures, Forms and Templates 10
N Chemical Oxygen Demand (COD) Determination in Industrial Waste Water General Measurement Device and Calibration Topics 5
R Demand Flow Technology vs. Lean Manufacturing - Same method with just another name? Lean in Manufacturing and Service Industries 9
N Replace, Repair, or Refund - Customer's Demand ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
1 Matching Supply with Customer Demand - Need help Manufacturing and Related Processes 5
B Identifying Peak Demand and Usage with Start/End Time - Hospital Hospitals, Clinics & other Health Care Providers 3
T DFT - Demand Flow Technology - Operational Sheets (WI) Document Control Systems, Procedures, Forms and Templates 4
Q Is there an international standard for Supply Chain, particularly (demand) planning? Various Other Specifications, Standards, and related Requirements 2
J Log in EVERY SINGLE defect caught and demand Corrective Action for each CAR? Preventive Action and Continuous Improvement 11
Marc Quality In Tourism And Demand From People With Reduced Capabilities Service Industry Specific Topics 5
T Survey - What is the demand of Pre-written/ready-to-use calibration procedures? General Measurement Device and Calibration Topics 14
Gman2 Automotive PPM Requirements - Our customer is trying to demand a 100% 0 defect rate IATF 16949 - Automotive Quality Systems Standard 3
W Demand of PPM evaluation suppliers Supplier Quality Assurance and other Supplier Issues 2
M Clinical evaluation process of FDA and MDR Medical Device and FDA Regulations and Standards News 2
G MDR CE Experation date EU Medical Device Regulations 1
C MDR vs CMDR EU Medical Device Regulations 4
O MDR language requirements EU Medical Device Regulations 12
K Whether the product is an accessory according to the MDR definition EU Medical Device Regulations 3
L Adverse Event Reporting Flowchart (MDR EU) EU Medical Device Regulations 3
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
Ed Panek MDR Delay? EU Medical Device Regulations 2
dgrainger Informational Proposal to address MDR challenges EU Medical Device Regulations 16
goldenguo MDR/IVDR Insurance and Liability for Manufacturers, EU Representative and Importer EU Medical Device Regulations 3
B MDR PSUR versus Canadian Summary report EU Medical Device Regulations 4
C MDR 2017/744 Article 22 EU Medical Device Regulations 3
K Sales of MDD devices with expired CE that are pending MDR certification EU Medical Device Regulations 4
D New Device Post Market Requirement for MDR EU Medical Device Regulations 3
D EU MDR Derogation EU Medical Device Regulations 0
Doninina Risk management file according MDR or ISO 14971:P2019 ? EU Medical Device Regulations 2
M EU MDR (GSPR Checklist) consolidated with TGA EP Checklist EU Medical Device Regulations 5
A PMSR or PSUR for legacy MDD-class I becoming MDR class-IIa EU Medical Device Regulations 8
H MDR clinical evaluation EU Medical Device Regulations 0
M Possible topic for Master thesis topic - MDR and QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
D Does the MDR article 10 (14) needs to be documented word for word in a Procedure? EU Medical Device Regulations 1
N Adding New Products during MDR transition period Manufacturing and Related Processes 1
L Internal Audits during the MDR Transition Period EU Medical Device Regulations 5
Z How to keep up with changes on applicable technical standards (EU MDR)? EU Medical Device Regulations 6
S OEM- Virtual Manufacturer contract MDR Quality Management System (QMS) Manuals 0
J TGA CER & EU MDR CER Requirements for Australia Other Medical Device Regulations World-Wide 3
G MDR DRAFT DoC EU Medical Device Regulations 7
F MDR Distributor EU Medical Device Regulations 6
Y EU MDR Technical Documentation - Defined Review EU Medical Device Regulations 1
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2

Similar threads

Top Bottom