Regulatory Open Forum

My recommendation is not to do a gap analysis.

This is a golden opportunity to start with fresh and create an efficient and effective risk management system.

I work with a lot of companies on risk management and I have never seen a simple or correct implementation following the standard. The propensity is to make the implementation overly complicated. The standard is a simple and straight forward process.

One company put their estimates for the market size and market share in the risk management plan.

One company believed the frequency of occurrence of harm depends on sales volume and included complicated tables to implement it.

Many companies try to calculate P1 and P2, which is impossible.

Another frequent problem is the risk management report. One company recently gave me a 150-page Risk Management Report when two pages would have been sufficient. They had not implemented the change from ISO 14971:2000 to ISO 14971:2007.

EN ISO 14971:2019 supersedes EN ISO 14971:2012, so this is the opportunity to fix all the incorrect things your NB required as they misunderstood the content deviations.

Note however, that EN ISO 14971:2019 does not fully align with the EU-MDR Annex I.

My recommendation is not to do a gap analysis.

This is a golden opportunity to start with fresh and create an efficient and effective risk management system.

I work with a lot of companies on risk management and I have never seen a simple or correct implementation following the standard. The propensity is to make the implementation overly complicated. The standard is a simple and straight forward process.

One company put their estimates for the market size and market share in the risk management plan.

One company believed the frequency of occurrence of harm depends on sales volume and included complicated tables to implement it.

Many companies try to calculate P1 and P2, which is impossible.

Another frequent problem is the risk management report. One company recently gave me a 150-page Risk Management Report when two pages would have been sufficient. They had not implemented the change from ISO 14971:2000 to ISO 14971:2007.

EN ISO 14971:2019 supersedes EN ISO 14971:2012, so this is the opportunity to fix all the incorrect things your NB required as they misunderstood the content deviations.

Note however, that EN ISO 14971:2019 does not fully align with the EU-MDR Annex I.

My recommendation is not to do a gap analysis.

This is a golden opportunity to start with fresh and create an efficient and effective risk management system.

I work with a lot of companies on risk management and I have never seen a simple or correct implementation following the standard. The propensity is to make the implementation overly complicated. The standard is a simple and straight forward process.

One company put their estimates for the market size and market share in the risk management plan.

One company believed the frequency of occurrence of harm depends on sales volume and included complicated tables to implement it.

Many companies try to calculate P1 and P2, which is impossible.

Another frequent problem is the risk management report. One company recently gave me a 150-page Risk Management Report when two pages would have been sufficient. They had not implemented the change from ISO 14971:2000 to ISO 14971:2007.

EN ISO 14971:2019 supersedes EN ISO 14971:2012, so this is the opportunity to fix all the incorrect things your NB required as they misunderstood the content deviations.

Note however, that EN ISO 14971:2019 does not fully align with the EU-MDR Annex I.

My recommendation is not to do a gap analysis.

This is a golden opportunity to start with fresh and create an efficient and effective risk management system.

I work with a lot of companies on risk management and I have never seen a simple or correct implementation following the standard. The propensity is to make the implementation overly complicated. The standard is a simple and straight forward process.

One company put their estimates for the market size and market share in the risk management plan.

One company believed the frequency of occurrence of harm depends on sales volume and included complicated tables to implement it.

Many companies try to calculate P1 and P2, which is impossible.

Another frequent problem is the risk management report. One company recently gave me a 150-page Risk Management Report when two pages would have been sufficient. They had not implemented the change from ISO 14971:2000 to ISO 14971:2007.

EN ISO 14971:2019 supersedes EN ISO 14971:2012, so this is the opportunity to fix all the incorrect things your NB required as they misunderstood the content deviations.

Note however, that EN ISO 14971:2019 does not fully align with the EU-MDR Annex I.

My recommendation is not to do a gap analysis.

This is a golden opportunity to start with fresh and create an efficient and effective risk management system.

I work with a lot of companies on risk management and I have never seen a simple or correct implementation following the standard. The propensity is to make the implementation overly complicated. The standard is a simple and straight forward process.

One company put their estimates for the market size and market share in the risk management plan.

One company believed the frequency of occurrence of harm depends on sales volume and included complicated tables to implement it.

Many companies try to calculate P1 and P2, which is impossible.

Another frequent problem is the risk management report. One company recently gave me a 150-page Risk Management Report when two pages would have been sufficient. They had not implemented the change from ISO 14971:2000 to ISO 14971:2007.

EN ISO 14971:2019 supersedes EN ISO 14971:2012, so this is the opportunity to fix all the incorrect things your NB required as they misunderstood the content deviations.

Note however, that EN ISO 14971:2019 does not fully align with the EU-MDR Annex I.

My recommendation is not to do a gap analysis.

This is a golden opportunity to start with fresh and create an efficient and effective risk management system.

I work with a lot of companies on risk management and I have never seen a simple or correct implementation following the standard. The propensity is to make the implementation overly complicated. The standard is a simple and straight forward process.

One company put their estimates for the market size and market share in the risk management plan.

One company believed the frequency of occurrence of harm depends on sales volume and included complicated tables to implement it.

Many companies try to calculate P1 and P2, which is impossible.

Another frequent problem is the risk management report. One company recently gave me a 150-page Risk Management Report when two pages would have been sufficient. They had not implemented the change from ISO 14971:2000 to ISO 14971:2007.

EN ISO 14971:2019 supersedes EN ISO 14971:2012, so this is the opportunity to fix all the incorrect things your NB required as they misunderstood the content deviations.

Note however, that EN ISO 14971:2019 does not fully align with the EU-MDR Annex I.

My recommendation is not to do a gap analysis.

This is a golden opportunity to start with fresh and create an efficient and effective risk management system.

I work with a lot of companies on risk management and I have never seen a simple or correct implementation following the standard. The propensity is to make the implementation overly complicated. The standard is a simple and straight forward process.

One company put their estimates for the market size and market share in the risk management plan.

One company believed the frequency of occurrence of harm depends on sales volume and included complicated tables to implement it.

Many companies try to calculate P1 and P2, which is impossible.

Another frequent problem is the risk management report. One company recently gave me a 150-page Risk Management Report when two pages would have been sufficient. They had not implemented the change from ISO 14971:2000 to ISO 14971:2007.

EN ISO 14971:2019 supersedes EN ISO 14971:2012, so this is the opportunity to fix all the incorrect things your NB required as they misunderstood the content deviations.

Note however, that EN ISO 14971:2019 does not fully align with the EU-MDR Annex I.