Adding New Products during MDR transition period

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K Medical device procedure tray - Adding products in Custom packs Other Medical Device and Orthopedic Related Topics 3
S FDA CDRH Premarket Review Submission Cover Sheet - adding more products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Adding new product code/Catalogue number to existing 510K US Medical Device Regulations 0
T Adding to certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
U Adding another Subcontractor EU Medical Device Regulations 3
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
S Complexity Rating - CB adding another audit day for "high complexity" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
E Adding models to an approved Russian Registration Certificate Other Medical Device Regulations World-Wide 1
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
D Adding a Class I to a sample box Canada Medical Device Regulations 5
K Adding the Notified Body Number CE Marking (Conformité Européene) / CB Scheme 2
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 13
P Adding "new" medical device to existing CER - under MDD CE Marking (Conformité Européene) / CB Scheme 1
F Adding a medical device in another medical device package EU Medical Device Regulations 2
K Relabeling or Not Relabeling - Adding our internal Part Number barcode label 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Adding Remote Site to Current IATF 16949 Certification IATF 16949 - Automotive Quality Systems Standard 2
S Adding Value prior to signing EASA Form 1 EASA and JAA Aviation Standards and Requirements 5
D Adding a new site to 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
S Adding claims on medical device labelling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Adding a UDI Compliant Label to previously manufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
4 Adding a new Company - ISO 9001 Design Exclusion Design and Development of Products and Processes 1
L IATF 16949: Adding a Remote Location between certifications IATF 16949 - Automotive Quality Systems Standard 2
T Adding an adapter to a Torque Meter to change the Range Capability, Accuracy and Stability - Processes, Machines, etc. 6
R Coexisting Investigational Use and CE-Mark - Adding a new Indication EU Medical Device Regulations 4
K Adding a New Site to Our ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 9
C Adding information to Labels - Class II Medical Devices US Food and Drug Administration (FDA) 1
D Adding an extra Label on an Ethylene Oxide Sterilized Box ISO 13485:2016 - Medical Device Quality Management Systems 3
E Adding a "Scope Statement " to my Quality Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
W Quality for value adding or certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
somashekar Adding an other process into the system - Authorised Economic Operator (AEO) Scheme ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Adding 1% error to data in a column in Minitab Using Minitab Software 3
M Is 510k Required for Adding a section on use of Disinfectants to Product Manual? US Food and Drug Administration (FDA) 3
D Adding PPAP forms to the ISO procedures Document Control Systems, Procedures, Forms and Templates 2
B What to do when adding new Proprietary name under same 510(k) Other US Medical Device Regulations 2
M PPAP requirements when adding Part Transfer Robots between Machines APQP and PPAP 1
M Adding AS9100C Lead Auditor Certification to an IRCA ISO 9001 LA Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Need help in adding second location to FDA Registration Other US Medical Device Regulations 4
K Adding a Disclaimer on an FMEA FMEA and Control Plans 4
M Adding Bizminer's Industry Financial data to my Peer Company Comparison Manufacturing and Related Processes 0
D Rounding Numbers - Adding numbers in Excel - I want the average Excel .xls Spreadsheet Templates and Tools 3
F Implementing ISO 11135 - Facilities Conditions - Adding ETO Sterilization Other Medical Device Related Standards 4
Q Adding to our A2LA Scope of Accreditation General Measurement Device and Calibration Topics 2
A ISO 9001 company now adding Welding to the Scope - What needs to change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
marmotte Adding a Funct. Earth. to a class II / BF device...retest needed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Document Changes not affecting the process - Adding Logos, etc. Document Control Systems, Procedures, Forms and Templates 8
V Option for adding date-time to the copies printed from Adobe Acrobat (pdf) Quality Assurance and Compliance Software Tools and Solutions 1
V What are the Value Adding Quality Assurance Processes and how to measure them? Quality Tools, Improvement and Analysis 3
P Can 'adding a new service' be a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7

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