Regulatory Open Forum

Happy New Year Regulatory people!   As I'm getting ready to dive back into work later this week after the holidays, I need your input on change management for device standards.

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.  

Here's my problem...  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.  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 gap analysis would be warranted, 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 info and/or advice you can share would be immensely appreciated.

Thanks!

Tina

Happy New Year Regulatory people!   As I'm getting ready to dive back into work later this week after the holidays, I need your input on change management for device standards.

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.  

Here's my problem...  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.  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 gap analysis would be warranted, 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 info and/or advice you can share would be immensely appreciated.

Thanks!

Tina

Happy New Year Regulatory people!   As I'm getting ready to dive back into work later this week after the holidays, I need your input on change management for device standards.

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.  

Here's my problem...  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.  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 gap analysis would be warranted, 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 info and/or advice you can share would be immensely appreciated.

Thanks!

Tina

Happy New Year Regulatory people!   As I'm getting ready to dive back into work later this week after the holidays, I need your input on change management for device standards.

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.  

Here's my problem...  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.  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 gap analysis would be warranted, 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 info and/or advice you can share would be immensely appreciated.

Thanks!

Tina

Happy New Year Regulatory people!   As I'm getting ready to dive back into work later this week after the holidays, I need your input on change management for device standards.

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.  

Here's my problem...  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.  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 gap analysis would be warranted, 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 info and/or advice you can share would be immensely appreciated.

Thanks!

Tina

Happy New Year Regulatory people!   As I'm getting ready to dive back into work later this week after the holidays, I need your input on change management for device standards.

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.  

Here's my problem...  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.  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 gap analysis would be warranted, 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 info and/or advice you can share would be immensely appreciated.

Thanks!

Tina

Happy New Year Regulatory people!   As I'm getting ready to dive back into work later this week after the holidays, I need your input on change management for device standards.

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.  

Here's my problem...  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.  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 gap analysis would be warranted, 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 info and/or advice you can share would be immensely appreciated.

Thanks!

Tina

Happy New Year Regulatory people!   As I'm getting ready to dive back into work later this week after the holidays, I need your input on change management for device standards.

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.  

Here's my problem...  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.  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 gap analysis would be warranted, 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 info and/or advice you can share would be immensely appreciated.

Thanks!

Tina