Device Standards - Managing Changes to existing standards that apply to our devices

funkgirl

Involved In Discussions
#1
After having spent the better part of the last 20 years working for large device companies with oodles of resources, systems, and processes, I am now with a very small company with few resources, so I'm the lucky person responsible for standards compliance and maintenance.

My team of standards "users" consists mostly of staff with little to no prior medical device experience, thus little to no practical experience in the use of standards. While I provide general training and guidance, I need the designated SMEs to become responsible for analysis and implementation of the technical aspects of their assigned standards. For example, the standards management SOP that I inherited when I joined the company requires that a clause-by-clause gap analysis be documented for all new standards and all revisions. IMO this is complete overkill and neither practical nor sustainable considering the other multiple hats each member of the team wears on a daily basis, so this is something I'd like to streamline and simplify in order to achieve and maintain SOP compliance.

What I REALLY need are suggestions as to HOW to best manage changes to existing standards that apply to our devices in a manner that is least cumbersome and most value-added. I'd love to be able to get my hands on anything – a process flow, checklist, SOP (really, anything would help) that provides some structure and guidance for the SMEs with respect to both new and revised standards, criteria for when a full documented gap analysis would be warranted (vs a 2-liner memo to file), best practices for documenting compliance to a standards, etc. While I do have some content of my own, I'd really like to incorporate recommendations that are proven to work. I'm also conducting a deep dive into the user features of the IHS Engineering Workbench to see what could be utilized by the SMEs to document their analysis of the standards outside of our paper-based QS.

Any and all info and/or advice you can share would be immensely appreciated.

Thanks!

Tina
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
I believe that the revision of the standard itself quotes what is changed TO from the existing, and at which clause, sub-clause / section, in an annex in the last pages.
So the new changed standard can in itself be your guide to manage change, provided the people know the device vis-a-vis the standard.
 
Thread starter Similar threads Forum Replies Date
J Medical device related standards or regulations - Disposed records log ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Interpreting China Medical Device regulations/standards China Medical Device Regulations 1
C How medical device manufacturers are implementing standards like GDPR and HIPAA Other ISO and International Standards and European Regulations 5
M Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Medical Device and FDA Regulations and Standards News 0
M CE/FCC/Industry Canada - Standards required for Certification for a Bluetooth Device CE Marking (Conformité Européene) / CB Scheme 6
S Keeping track of the changing Medical Device Standards Other Medical Device Related Standards 3
L Medical Device Electrical Safety Standards - Gap Analysis of Latest Revisions Other ISO and International Standards and European Regulations 2
H Standards to use for Propylene Glycol Heat/Cooler Fluid in a Device RoHS, REACH, ELV, IMDS and Restricted Substances 2
R Standards Specific to Single Channel ECG Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
G How do Medical Device Standards vs Directive vs Regulation technically vary? Other Medical Device and Orthopedic Related Topics 7
C CFDA announced 120 new Medical Device Standards - July 2014 China Medical Device Regulations 0
N Regulatory and Safety Standards for Medical Device with Measuring Function IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
R Applicable Medical Device Standards for Home Use Blood Pressure Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T The CFDA recently issued new Medical Device Industry Standards China Medical Device Regulations 0
M Revision of ISO 16142 - Clause on use of standards in the medical device life-cycle Other Medical Device Related Standards 3
Sam Lazzara Medical Device Standards Identification 101 article Other Medical Device Regulations World-Wide 2
J Identifying version of Standards in Functional Specification of a New Device ISO 13485:2016 - Medical Device Quality Management Systems 6
P Specific requirements for filtering in Medical Device Standards IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
P Which Medical Device Standards to Buy IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
N Medical Device External Standards Control and Monitoring Other US Medical Device Regulations 10
M Service for Supersede Dates of Medical Device Standards? Other Medical Device Related Standards 3
R Medical Device Labeling Standards References 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
Marc Medical Device Standards - Difference between IEC and EN Standards Other Medical Device Related Standards 13
B Definition Diagnostic - Is "diagnostic" defined in the EU Medical Device Standards? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 10
M Medical Device Regulatory Standards Update Services IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
S Canada - CSA C22.2 Medical Device Standards Other Medical Device Related Standards 1
D Standards concerning Medical Device Battery Charging DURING Use Other Medical Device Related Standards 3
Sam Lazzara Medical Device Harmonised Standards Update - May 2011 CE Marking (Conformité Européene) / CB Scheme 0
M Clarifying the many different Medical Device national and international standards Other Medical Device Related Standards 4
O Harmonized Standards on Medical Device IFU (Instructions for Use) ISO 13485:2016 - Medical Device Quality Management Systems 7
xcanals_tecno-med.es Revised List of Harmonized Standards for Medical Device Directives (MDD) in the EU EU Medical Device Regulations 48
B Define "Rework" Under Medical Device Standards ISO 13485:2016 - Medical Device Quality Management Systems 10
xcanals_tecno-med.es Revised list of harmonized standards for medical device directives in the EU (7/7/10) EU Medical Device Regulations 0
L ISO 13485 - Overwhelmed by various Medical Device standards ISO 13485:2016 - Medical Device Quality Management Systems 2
arios Guidance Standards for Medical Device Manufacturer Pest Control Other Medical Device Related Standards 6
S Searching for applicable Standards for a Medical Device using electronics, software Other Medical Device Related Standards 11
R Medical Device: New List of Harmonized Standards in EU under MDD93/42/EEC EU Medical Device Regulations 6
M Revised list of harmonized standards for medical device directives in the EU EU Medical Device Regulations 1
M Implementation period for standards - CE renewal submission - Class II medical device EU Medical Device Regulations 3
SteveK Standards used for Medical Device MDD Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 25
S Relevant Packaging Standards for Medical Device Package testing ISO 13485:2016 - Medical Device Quality Management Systems 9
W New List of Medical Device Harmonized Standards - MDD CE Marking (Conformité Européene) / CB Scheme 5
T What are the standards needed for an electro-acupuncture device? ISO 13485:2016 - Medical Device Quality Management Systems 10
Y Water Disinfection Device - UV sterilization device - What standards do we need? Food Safety - ISO 22000, HACCP (21 CFR 120) 6
S Environmental Control Standards - Sterile medical device manufacturing environment ISO 13485:2016 - Medical Device Quality Management Systems 3
R Device Labeling Standards: Is ISO 15223:2000 Replacing EN980? ISO 13485:2016 - Medical Device Quality Management Systems 3
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 7
Similar threads


















































Top Bottom