Regulatory Open Forum

It may be difficult to successfully assert that a CEO isn't allowed to be the EU MDR PRRC.  Such an assertion would need to be carefully approached and, in many cases, may be impossible to sustain.  Let me explain.

Beginning nearly thirty years ago with ISO 9001:1994 / EN ISO 9001:1994 and EN 46001:1996 (perhaps even earlier), quality management system (QMS) standards began placing ultimate accountability and responsibility for compliance squarely on the shoulders of management with executive responsibility (a.k.a., top management, e.g., a CEO).  That new level of management responsibility came about to guard against top management being more committed to sales and growth than to compliance.  The shifting of ultimate responsibility for compliance to top management was aimed at intrinsically helping alleviate company bias against quality / regulatory.

This remained the case when ISO 9001 and EN 46001 led to ISO 13485.  With ISO 13485:2016 came increased emphasis and management responsibility for compliance with applicable regulatory requirements (such as compliance with the EU MDR).  Moreover, the EU MDR's own quality management system clause [Article 10(9)] also includes a provision alluding to such management responsibility.

Accordingly, if an organization chooses ISO 13485:2016 (or even if it applies a different QMS paradigm) as its means for conforming with the EU MDR's QMS and management responsibility requirements, then I think it's important to remember that neither EU MDR Article 10(9), nor ISO 13485:2016 clause 5, nor EU MDR Article 15 (by my interpretation) prohibit a CEO from being the PRRC.  This of course comes with the prerequisite that the CEO must possess the medical device regulatory/quality qualifications prescribed by Article 15.

Because ISO 13485:2016 systematically and specifically prohibits, and ultimately prevents, top management from practicing bias against regulatory compliance, I don't think an argument of bias can be easily sustained against a CEO as EU MDR PRRC.

It may be difficult to successfully assert that a CEO isn't allowed to be the EU MDR PRRC.  Such an assertion would need to be carefully approached and, in many cases, may be impossible to sustain.  Let me explain.

Beginning nearly thirty years ago with ISO 9001:1994 / EN ISO 9001:1994 and EN 46001:1996 (perhaps even earlier), quality management system (QMS) standards began placing ultimate accountability and responsibility for compliance squarely on the shoulders of management with executive responsibility (a.k.a., top management, e.g., a CEO).  That new level of management responsibility came about to guard against top management being more committed to sales and growth than to compliance.  The shifting of ultimate responsibility for compliance to top management was aimed at intrinsically helping alleviate company bias against quality / regulatory.

This remained the case when ISO 9001 and EN 46001 led to ISO 13485.  With ISO 13485:2016 came increased emphasis and management responsibility for compliance with applicable regulatory requirements (such as compliance with the EU MDR).  Moreover, the EU MDR's own quality management system clause [Article 10(9)] also includes a provision alluding to such management responsibility.

Accordingly, if an organization chooses ISO 13485:2016 (or even if it applies a different QMS paradigm) as its means for conforming with the EU MDR's QMS and management responsibility requirements, then I think it's important to remember that neither EU MDR Article 10(9), nor ISO 13485:2016 clause 5, nor EU MDR Article 15 (by my interpretation) prohibit a CEO from being the PRRC.  This of course comes with the prerequisite that the CEO must possess the medical device regulatory/quality qualifications prescribed by Article 15.

Because ISO 13485:2016 systematically and specifically prohibits, and ultimately prevents, top management from practicing bias against regulatory compliance, I don't think an argument of bias can be easily sustained against a CEO as EU MDR PRRC.

It may be difficult to successfully assert that a CEO isn't allowed to be the EU MDR PRRC.  Such an assertion would need to be carefully approached and, in many cases, may be impossible to sustain.  Let me explain.

Beginning nearly thirty years ago with ISO 9001:1994 / EN ISO 9001:1994 and EN 46001:1996 (perhaps even earlier), quality management system (QMS) standards began placing ultimate accountability and responsibility for compliance squarely on the shoulders of management with executive responsibility (a.k.a., top management, e.g., a CEO).  That new level of management responsibility came about to guard against top management being more committed to sales and growth than to compliance.  The shifting of ultimate responsibility for compliance to top management was aimed at intrinsically helping alleviate company bias against quality / regulatory.

This remained the case when ISO 9001 and EN 46001 led to ISO 13485.  With ISO 13485:2016 came increased emphasis and management responsibility for compliance with applicable regulatory requirements (such as compliance with the EU MDR).  Moreover, the EU MDR's own quality management system clause [Article 10(9)] also includes a provision alluding to such management responsibility.

Accordingly, if an organization chooses ISO 13485:2016 (or even if it applies a different QMS paradigm) as its means for conforming with the EU MDR's QMS and management responsibility requirements, then I think it's important to remember that neither EU MDR Article 10(9), nor ISO 13485:2016 clause 5, nor EU MDR Article 15 (by my interpretation) prohibit a CEO from being the PRRC.  This of course comes with the prerequisite that the CEO must possess the medical device regulatory/quality qualifications prescribed by Article 15.

Because ISO 13485:2016 systematically and specifically prohibits, and ultimately prevents, top management from practicing bias against regulatory compliance, I don't think an argument of bias can be easily sustained against a CEO as EU MDR PRRC.

It may be difficult to successfully assert that a CEO isn't allowed to be the EU MDR PRRC.  Such an assertion would need to be carefully approached and, in many cases, may be impossible to sustain.  Let me explain.

Beginning nearly thirty years ago with ISO 9001:1994 / EN ISO 9001:1994 and EN 46001:1996 (perhaps even earlier), quality management system (QMS) standards began placing ultimate accountability and responsibility for compliance squarely on the shoulders of management with executive responsibility (a.k.a., top management, e.g., a CEO).  That new level of management responsibility came about to guard against top management being more committed to sales and growth than to compliance.  The shifting of ultimate responsibility for compliance to top management was aimed at intrinsically helping alleviate company bias against quality / regulatory.

This remained the case when ISO 9001 and EN 46001 led to ISO 13485.  With ISO 13485:2016 came increased emphasis and management responsibility for compliance with applicable regulatory requirements (such as compliance with the EU MDR).  Moreover, the EU MDR's own quality management system clause [Article 10(9)] also includes a provision alluding to such management responsibility.

Accordingly, if an organization chooses ISO 13485:2016 (or even if it applies a different QMS paradigm) as its means for conforming with the EU MDR's QMS and management responsibility requirements, then I think it's important to remember that neither EU MDR Article 10(9), nor ISO 13485:2016 clause 5, nor EU MDR Article 15 (by my interpretation) prohibit a CEO from being the PRRC.  This of course comes with the prerequisite that the CEO must possess the medical device regulatory/quality qualifications prescribed by Article 15.

Because ISO 13485:2016 systematically and specifically prohibits, and ultimately prevents, top management from practicing bias against regulatory compliance, I don't think an argument of bias can be easily sustained against a CEO as EU MDR PRRC.

It may be difficult to successfully assert that a CEO isn't allowed to be the EU MDR PRRC.  Such an assertion would need to be carefully approached and, in many cases, may be impossible to sustain.  Let me explain.

Beginning nearly thirty years ago with ISO 9001:1994 / EN ISO 9001:1994 and EN 46001:1996 (perhaps even earlier), quality management system (QMS) standards began placing ultimate accountability and responsibility for compliance squarely on the shoulders of management with executive responsibility (a.k.a., top management, e.g., a CEO).  That new level of management responsibility came about to guard against top management being more committed to sales and growth than to compliance.  The shifting of ultimate responsibility for compliance to top management was aimed at intrinsically helping alleviate company bias against quality / regulatory.

This remained the case when ISO 9001 and EN 46001 led to ISO 13485.  With ISO 13485:2016 came increased emphasis and management responsibility for compliance with applicable regulatory requirements (such as compliance with the EU MDR).  Moreover, the EU MDR's own quality management system clause [Article 10(9)] also includes a provision alluding to such management responsibility.

Accordingly, if an organization chooses ISO 13485:2016 (or even if it applies a different QMS paradigm) as its means for conforming with the EU MDR's QMS and management responsibility requirements, then I think it's important to remember that neither EU MDR Article 10(9), nor ISO 13485:2016 clause 5, nor EU MDR Article 15 (by my interpretation) prohibit a CEO from being the PRRC.  This of course comes with the prerequisite that the CEO must possess the medical device regulatory/quality qualifications prescribed by Article 15.

Because ISO 13485:2016 systematically and specifically prohibits, and ultimately prevents, top management from practicing bias against regulatory compliance, I don't think an argument of bias can be easily sustained against a CEO as EU MDR PRRC.

It may be difficult to successfully assert that a CEO isn't allowed to be the EU MDR PRRC.  Such an assertion would need to be carefully approached and, in many cases, may be impossible to sustain.  Let me explain.

Beginning nearly thirty years ago with ISO 9001:1994 / EN ISO 9001:1994 and EN 46001:1996 (perhaps even earlier), quality management system (QMS) standards began placing ultimate accountability and responsibility for compliance squarely on the shoulders of management with executive responsibility (a.k.a., top management, e.g., a CEO).  That new level of management responsibility came about to guard against top management being more committed to sales and growth than to compliance.  The shifting of ultimate responsibility for compliance to top management was aimed at intrinsically helping alleviate company bias against quality / regulatory.

This remained the case when ISO 9001 and EN 46001 led to ISO 13485.  With ISO 13485:2016 came increased emphasis and management responsibility for compliance with applicable regulatory requirements (such as compliance with the EU MDR).  Moreover, the EU MDR's own quality management system clause [Article 10(9)] also includes a provision alluding to such management responsibility.

Accordingly, if an organization chooses ISO 13485:2016 (or even if it applies a different QMS paradigm) as its means for conforming with the EU MDR's QMS and management responsibility requirements, then I think it's important to remember that neither EU MDR Article 10(9), nor ISO 13485:2016 clause 5, nor EU MDR Article 15 (by my interpretation) prohibit a CEO from being the PRRC.  This of course comes with the prerequisite that the CEO must possess the medical device regulatory/quality qualifications prescribed by Article 15.

Because ISO 13485:2016 systematically and specifically prohibits, and ultimately prevents, top management from practicing bias against regulatory compliance, I don't think an argument of bias can be easily sustained against a CEO as EU MDR PRRC.

It may be difficult to successfully assert that a CEO isn't allowed to be the EU MDR PRRC.  Such an assertion would need to be carefully approached and, in many cases, may be impossible to sustain.  Let me explain.

Beginning nearly thirty years ago with ISO 9001:1994 / EN ISO 9001:1994 and EN 46001:1996 (perhaps even earlier), quality management system (QMS) standards began placing ultimate accountability and responsibility for compliance squarely on the shoulders of management with executive responsibility (a.k.a., top management, e.g., a CEO).  That new level of management responsibility came about to guard against top management being more committed to sales and growth than to compliance.  The shifting of ultimate responsibility for compliance to top management was aimed at intrinsically helping alleviate company bias against quality / regulatory.

This remained the case when ISO 9001 and EN 46001 led to ISO 13485.  With ISO 13485:2016 came increased emphasis and management responsibility for compliance with applicable regulatory requirements (such as compliance with the EU MDR).  Moreover, the EU MDR's own quality management system clause [Article 10(9)] also includes a provision alluding to such management responsibility.

Accordingly, if an organization chooses ISO 13485:2016 (or even if it applies a different QMS paradigm) as its means for conforming with the EU MDR's QMS and management responsibility requirements, then I think it's important to remember that neither EU MDR Article 10(9), nor ISO 13485:2016 clause 5, nor EU MDR Article 15 (by my interpretation) prohibit a CEO from being the PRRC.  This of course comes with the prerequisite that the CEO must possess the medical device regulatory/quality qualifications prescribed by Article 15.

Because ISO 13485:2016 systematically and specifically prohibits, and ultimately prevents, top management from practicing bias against regulatory compliance, I don't think an argument of bias can be easily sustained against a CEO as EU MDR PRRC.

It may be difficult to successfully assert that a CEO isn't allowed to be the EU MDR PRRC.  Such an assertion would need to be carefully approached and, in many cases, may be impossible to sustain.  Let me explain.

Beginning nearly thirty years ago with ISO 9001:1994 / EN ISO 9001:1994 and EN 46001:1996 (perhaps even earlier), quality management system (QMS) standards began placing ultimate accountability and responsibility for compliance squarely on the shoulders of management with executive responsibility (a.k.a., top management, e.g., a CEO).  That new level of management responsibility came about to guard against top management being more committed to sales and growth than to compliance.  The shifting of ultimate responsibility for compliance to top management was aimed at intrinsically helping alleviate company bias against quality / regulatory.

This remained the case when ISO 9001 and EN 46001 led to ISO 13485.  With ISO 13485:2016 came increased emphasis and management responsibility for compliance with applicable regulatory requirements (such as compliance with the EU MDR).  Moreover, the EU MDR's own quality management system clause [Article 10(9)] also includes a provision alluding to such management responsibility.

Accordingly, if an organization chooses ISO 13485:2016 (or even if it applies a different QMS paradigm) as its means for conforming with the EU MDR's QMS and management responsibility requirements, then I think it's important to remember that neither EU MDR Article 10(9), nor ISO 13485:2016 clause 5, nor EU MDR Article 15 (by my interpretation) prohibit a CEO from being the PRRC.  This of course comes with the prerequisite that the CEO must possess the medical device regulatory/quality qualifications prescribed by Article 15.

Because ISO 13485:2016 systematically and specifically prohibits, and ultimately prevents, top management from practicing bias against regulatory compliance, I don't think an argument of bias can be easily sustained against a CEO as EU MDR PRRC.

It may be difficult to successfully assert that a CEO isn't allowed to be the EU MDR PRRC.  Such an assertion would need to be carefully approached and, in many cases, may be impossible to sustain.  Let me explain.

Beginning nearly thirty years ago with ISO 9001:1994 / EN ISO 9001:1994 and EN 46001:1996 (perhaps even earlier), quality management system (QMS) standards began placing ultimate accountability and responsibility for compliance squarely on the shoulders of management with executive responsibility (a.k.a., top management, e.g., a CEO).  That new level of management responsibility came about to guard against top management being more committed to sales and growth than to compliance.  The shifting of ultimate responsibility for compliance to top management was aimed at intrinsically helping alleviate company bias against quality / regulatory.

This remained the case when ISO 9001 and EN 46001 led to ISO 13485.  With ISO 13485:2016 came increased emphasis and management responsibility for compliance with applicable regulatory requirements (such as compliance with the EU MDR).  Moreover, the EU MDR's own quality management system clause [Article 10(9)] also includes a provision alluding to such management responsibility.

Accordingly, if an organization chooses ISO 13485:2016 (or even if it applies a different QMS paradigm) as its means for conforming with the EU MDR's QMS and management responsibility requirements, then I think it's important to remember that neither EU MDR Article 10(9), nor ISO 13485:2016 clause 5, nor EU MDR Article 15 (by my interpretation) prohibit a CEO from being the PRRC.  This of course comes with the prerequisite that the CEO must possess the medical device regulatory/quality qualifications prescribed by Article 15.

Because ISO 13485:2016 systematically and specifically prohibits, and ultimately prevents, top management from practicing bias against regulatory compliance, I don't think an argument of bias can be easily sustained against a CEO as EU MDR PRRC.