Maintaining Technical Documentation under MDD and MDR

#1
Is it true that , when unpdating the techinical documentation under MDD (and soon MDR) all processes described in the technical documentation must be implemented in accordance with the applicable quality procedures in force? Of course risk managment and clinical evaluation must be periodically updated. But what if, for example, a device whas designed using a design control procedure that was later revised? Does it mean that all the DHF needs to be updated according to the new procedure?
 
Elsmar Forum Sponsor

indubioush

Quite Involved in Discussions
#2
Can you be more specific with your question. Your design history file is your technical documentation that will show how you meet the MDR requirements. This means you will need to update your documents or create new documents where needed to show compliance.
 
Thread starter Similar threads Forum Replies Date
J Software for maintaining of Technical files and medical device documentation(RA need) Medical Information Technology, Medical Software and Health Informatics 2
A CE Mark - Maintaining Technical File and Regulatory Assessment CE Marking (Conformité Européene) / CB Scheme 1
S Maintaining Equipment Records - We use a manual system ISO 17025 related Discussions 1
B Main responsibility for Control Plans - creating and maintaining FMEA and Control Plans 13
P Procedure for maintaining Confidentiality And Impartiality in a Laboratory Quality Management System (QMS) Manuals 2
G Maintaining of Performance during the Lifetime of a IIa Medical Device EU Medical Device Regulations 5
Crimpshrine13 Rules of achieving and maintaining IATF recognition - Determining audit days IATF 16949 - Automotive Quality Systems Standard 2
B What is our requirement for maintaining the EMC series of standards? IEC 61000 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
JoCam Cost of maintaining CE Mark Regulatory Approval Other Medical Device Regulations World-Wide 3
W Maintaining Component Traceability in DHR (Design History Record) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V Maintaining an E-Record for Equipment Data Qualification and Validation (including 21 CFR Part 11) 4
D Redundant BOMs - Maintaining a Reference Only BOM on our Top Level Assembly Drawings Document Control Systems, Procedures, Forms and Templates 7
D Procedure for Maintaining Industry Standards and Identifying Revisions Document Control Systems, Procedures, Forms and Templates 1
H Source for Compiling and Maintaining an EHS Legal Register Miscellaneous Environmental Standards and EMS Related Discussions 4
S Advice on moving QMS Documents and Maintaining Revision History Quality Manager and Management Related Issues 9
M AS9100 Rev C - Determining, Providing and Maintaining" Infrastructure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
S Maintaining ISO 9001:2008 when Automotive Business is Slow ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Requirements - Controlling and Maintaining Sheet Metal Templates for Production Use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
N ISO 9001 based Audit Schedules: Creating and Maintaining - Template wanted General Auditing Discussions 5
S What's the logical difference between maintaining & retaining records of review? Management Review Meetings and related Processes 10
S A question on Maintaining the Integrity of the QMS (5.4.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C API Q1 8th ed/ISO TS 29001 Maintaining Responsibility for Outsourced Processes Oil and Gas Industry Standards and Regulations 6
S Quality Manual - Possibility of maintaining only SOFT COPIES Quality Management System (QMS) Manuals 17
A Maintaining Dual Standards ISO 9001 and ISO 13485 - Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
T How many hours a week do you devote to maintaining your QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
A Rechargeable Battery in Medical Device - Controling and Maintaining Batteries Other Medical Device and Orthopedic Related Topics 4
G Calibration laboratory start-up - Maintaining the same ambient conditions General Measurement Device and Calibration Topics 7
ScottK Maintaining an SPC program with reduced staffing Statistical Analysis Tools, Techniques and SPC 8
B Specifications - Maintaining current revisions Document Control Systems, Procedures, Forms and Templates 6
Sidney Vianna Maintaining Accredited Certification During the Global Financial Crisis Registrars and Notified Bodies 9
Colin Cost of Maintaining Auditor Certification (IRCA QMS Lead Auditor) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
A Review and Verification for Maintaining Software Software Quality Assurance 10
Z Creating and Maintaining a Top Ten Poor Quality Supplier Performer List Supplier Quality Assurance and other Supplier Issues 16
T Plug Gages - How people are maintaining calibration on plug gages General Measurement Device and Calibration Topics 3
Q Production on Plastics Drums - Process Flow and Maintaining Cleanliness Manufacturing and Related Processes 2
apestate Advice on maintaining surface plate condition - Starrett crystal pink surface plate Inspection, Prints (Drawings), Testing, Sampling and Related Topics 14
gard2372 Implementation and Maintaining Lean Guide book - Seeking recommendations and reviews Book, Video, Blog and Web Site Reviews and Recommendations 10
A Maintaining traceability through our manufacturing process - Protective suits - 110 Misc. Quality Assurance and Business Systems Related Topics 1
G How is everyone handling TS2 Clause 8.2.3.1 - Maintaining Process Capability IATF 16949 - Automotive Quality Systems Standard 2
S Maintaining and tracking laboratory voltage standards - A2LA audit General Measurement Device and Calibration Topics 3
H Maintaining Certification - Do you need to take the test again? Professional Certifications and Degrees 5
P TS 16949 Clause 8.2.3.1 - Maintaining Process Capability IATF 16949 - Automotive Quality Systems Standard 9
R Guidance for 'Maintaining Compliance to 820 - FDA and ISO 13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 8
R Maintaining manufactoring process capability IATF 16949 - Automotive Quality Systems Standard 6
E Procedure Numbering Change? Still the need for maintaining Level 1, 2, 3, documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
T Maintaining Process Control QS-9000 - American Automotive Manufacturers Standard 1
M 4.9.2 Maintaining Process Control - Maintaining ongoing process capability QS-9000 - American Automotive Manufacturers Standard 13
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1

Similar threads

Top Bottom