MDCG 2020 Guidance on significant changes- Review, problems and tipsAntonio Bartolozzi
I express my personal point of view about the Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
Prepare your medical device for market with this Action List that walks you through the complexities of IEC 62304
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
Agile Computer System Validation of software productsWolfgang Kuchinke
Personalized medicine seems to be a potential solution to the known challenges facing clinical research and drug development. To be employed in clinical research, software tools must undergo a process called Computer System Validation (CSV) for compliance with legal requirements and Good Clinical Practice (GCP). Four academic developer groups of the EU project p-medicine were surveyed to evaluate the readiness of their developed software products to be used for clinical research. The analysis of the survey showed that considerable gaps exist in tool maintenance, quality management and compliance documentation. Because all developer groups use agile development methods, recommendations for agile quality assurance were developed as well as for using agile methods to establish “compliance by design”. We show how agile validation can be established by small modifications of sprint processes.
MDCG 2020 Guidance on significant changes- Review, problems and tipsAntonio Bartolozzi
I express my personal point of view about the Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
Prepare your medical device for market with this Action List that walks you through the complexities of IEC 62304
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
Agile Computer System Validation of software productsWolfgang Kuchinke
Personalized medicine seems to be a potential solution to the known challenges facing clinical research and drug development. To be employed in clinical research, software tools must undergo a process called Computer System Validation (CSV) for compliance with legal requirements and Good Clinical Practice (GCP). Four academic developer groups of the EU project p-medicine were surveyed to evaluate the readiness of their developed software products to be used for clinical research. The analysis of the survey showed that considerable gaps exist in tool maintenance, quality management and compliance documentation. Because all developer groups use agile development methods, recommendations for agile quality assurance were developed as well as for using agile methods to establish “compliance by design”. We show how agile validation can be established by small modifications of sprint processes.
Breakout Session: Cybersecurity in Medical DevicesHealthegy
Presentation by PwC at Medtech Conference 2016.
Participant:
Geoff Fisher, Director – PwC
Powered by:
Healthegy
For more healthcare innovation
Visit us at Healthegy.com
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
This article discusses how to perform installation qualification of pharmaceutical equipment. It outlines practical format of Installation Qualification and provides checklist for effectively performing Installation Qualification of pharmaceutical equipment.
Risk Management in IES 60601. Medical Devices, Creation and content of RMF, Methods for the visualization and identification of harms and hazards,
Creating a RMF – Minimal Documentation,
Common errors when creating a RMF.
The European Commission has published the final EU Guidelines for Complaints, Quality Defects and Product Recalls.
Significant changes have been made to this Chapter which now reflect that Quality Risk Management principles should be applied when investigating quality defects or complaints and when making decisions in relation to product recalls or other risk-mitigating actions. This presentation captures the new requirements.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
Організація та проведення внутрішніх аудитів та аудитів постачальників.Improve Medical LLC
1.Вимоги до проведення аудиту постачальника згідно ДСТУ EN ISO 13485:2018.
2. Поняття дистанційного аудиту постачальника. Складові дистанційного аудиту.
3. Організація та проведення внутрішніх аудитів. Результативний внутрішній аудит.
4. Компетентність внутрішніх аудиторів: можливі варіанти забезпечення компетентності.
Вебінар є безкоштовним за умови реєстраці за посиланням
A comprehensive description of the new requirements introduced by ISO 14971:2019 Application of risk management to medical devices and ISO/TR 24971 Technical Report for the FDA, MDR and IVDR
This presentation was delivered as a webinar for FDAnews, delving into software, medical devices and managing risk with 21 CFR Part 11 and IEC 62304. It provides:
• A historical backdrop of IEC 62304
• An overview of IEC 62304
• Implementing IEC 62304
• Common pitfalls to avoid
Webinar: Europe's new Medical Device Regulations (MDR)EMERGO
WATCH the recorded webinar here: http://www.emergogroup.com/resources/video-webinar-europe-mdr-changes
The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect until early 2020, smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute, overwhelming EU Notified Bodies. Ronald Boumans, Senior Global Regulatory Consultant for EMERGO (and former IGZ compliance inspector in The Netherlands) outlines the most important changes you need to know in this 35 minute recorded webinar from September 2016. Topics addressed include:
How the MDR is organized
Scope of the legislation
Device classification rules
New clinical evaluation requirements
UDI and EUDAMED database
Adverse event reporting
And much more...
What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.
This article explains what IEC 62304 is, when medical devices must comply with it and how IEC 62304 compliance is assessed.
Prioritizing Documentation for MDR Transition PlanningGreenlight Guru
This session will discuss the one year delay of the MDR date of application as well as some strategies to employ during the MDR Transition. In addition, some approaches for determining documents to prioritize for the transition will be discussed.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Breakout Session: Cybersecurity in Medical DevicesHealthegy
Presentation by PwC at Medtech Conference 2016.
Participant:
Geoff Fisher, Director – PwC
Powered by:
Healthegy
For more healthcare innovation
Visit us at Healthegy.com
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
This article discusses how to perform installation qualification of pharmaceutical equipment. It outlines practical format of Installation Qualification and provides checklist for effectively performing Installation Qualification of pharmaceutical equipment.
Risk Management in IES 60601. Medical Devices, Creation and content of RMF, Methods for the visualization and identification of harms and hazards,
Creating a RMF – Minimal Documentation,
Common errors when creating a RMF.
The European Commission has published the final EU Guidelines for Complaints, Quality Defects and Product Recalls.
Significant changes have been made to this Chapter which now reflect that Quality Risk Management principles should be applied when investigating quality defects or complaints and when making decisions in relation to product recalls or other risk-mitigating actions. This presentation captures the new requirements.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
Організація та проведення внутрішніх аудитів та аудитів постачальників.Improve Medical LLC
1.Вимоги до проведення аудиту постачальника згідно ДСТУ EN ISO 13485:2018.
2. Поняття дистанційного аудиту постачальника. Складові дистанційного аудиту.
3. Організація та проведення внутрішніх аудитів. Результативний внутрішній аудит.
4. Компетентність внутрішніх аудиторів: можливі варіанти забезпечення компетентності.
Вебінар є безкоштовним за умови реєстраці за посиланням
A comprehensive description of the new requirements introduced by ISO 14971:2019 Application of risk management to medical devices and ISO/TR 24971 Technical Report for the FDA, MDR and IVDR
This presentation was delivered as a webinar for FDAnews, delving into software, medical devices and managing risk with 21 CFR Part 11 and IEC 62304. It provides:
• A historical backdrop of IEC 62304
• An overview of IEC 62304
• Implementing IEC 62304
• Common pitfalls to avoid
Webinar: Europe's new Medical Device Regulations (MDR)EMERGO
WATCH the recorded webinar here: http://www.emergogroup.com/resources/video-webinar-europe-mdr-changes
The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect until early 2020, smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute, overwhelming EU Notified Bodies. Ronald Boumans, Senior Global Regulatory Consultant for EMERGO (and former IGZ compliance inspector in The Netherlands) outlines the most important changes you need to know in this 35 minute recorded webinar from September 2016. Topics addressed include:
How the MDR is organized
Scope of the legislation
Device classification rules
New clinical evaluation requirements
UDI and EUDAMED database
Adverse event reporting
And much more...
What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.
This article explains what IEC 62304 is, when medical devices must comply with it and how IEC 62304 compliance is assessed.
Prioritizing Documentation for MDR Transition PlanningGreenlight Guru
This session will discuss the one year delay of the MDR date of application as well as some strategies to employ during the MDR Transition. In addition, some approaches for determining documents to prioritize for the transition will be discussed.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
5 Things To Consider When Making A Change To An Existing Medical DeviceEMMAIntl
In this constantly changing world, it is important that your products keep up with the latest technology available. With medical devices now being in the form of wearables, long gone are the days when patients needed to be hooked up to a system to monitor their health.
Continuously improving your product requires you to make changes, and some of these changes may require notifying the FDA in the form of supplemental reports, 510(k)s, etc...
Phụ lục 11 về Hệ thống máy tính trong bộ tiêu chuẩn GMP EU. Xem thêm các tài liệu khác trên kênh Slideshare của Công ty cổ phần Tư vấn thiết kế GMP EU.
Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in the production of the device or in implementation of the device manufacturer's quality system. Any medical device software developed after June 1, 1997, regardless of its class, unless exempted in a classification regulation is subject to design controls...
A survey by Schneider Electric in the US revealed that predictive maintenance services can lead to 25% reduction in cost. Learn about industrial IoT framework that enables PdM
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Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
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Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
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MDR- Significant changes in the design and intended purpose
1. 1
MDR - Significant changes in the design and
intended purpose – Software changes,
Problems & Tips
Antonio Bartolozzi
antonio.bartolozzi@bartolozzi.it 18/06/2019
Feature Value Tollerance Giustification
Max GUI
Response Time
< 9s
Seconds
± 1s See Robert B Miller
1968; Card et al. 1991
Password
lenght
(security)
> 15char. 0 See guideline
SecurityU12.doc
Boot time < 20s ± 1s Intended Env. : no
intensive care rooms
2. 2antonio.bartolozzi@bartolozzi.it
Class I and significant changes
Art120.3 By way of derogation from Article 5 of this Regulation, a device
which is a class I device pursuant to Directive 93/42/EEC, for which the
declaration of conformity was drawn up prior to 26 May 2020 and for which
the conformity assessment procedure pursuant to this Regulation requires
the involvement of a notified body, or which has a certificate that was issued
in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is
valid by virtue of paragraph 2 of this Article, may be placed on the market or
put into service until 26 May 2024, provided that from 26 May 2020 it
continues to comply with either of those Directives, and provided there are
no significant changes in the design and intended purpose. However, the
requirements of this Regulation relating to post-market surveillance, market
surveillance, vigilance, registration of economic operators and of devices
shall apply in place of the corresponding requirements in those Directives.
3. 3antonio.bartolozzi@bartolozzi.it
NBOG GuideLine - MDD
NBOG’s Best Practice Guide 2014-3
Guidance for manufacturers and Notified Bodies on
reporting of Design Changes and Changes of the
Quality System
Is it applicable to the MDR ?
Short Answer : Yes (with discernment )
4. 4antonio.bartolozzi@bartolozzi.it
MDR – UDI - software changes
ANNEX VI
6.5.2. A new UDI-DI shall be required whenever there is a modification
that changes:
(a) the original performance;
(b) the safety or the intended use of the software;
(c) interpretation of data.
Such modifications include new or modified algorithms, database structures,
operating platform, architecture or new user interfaces or new channels for
interoperability.
New UDI Required Significant design change
6. 6antonio.bartolozzi@bartolozzi.it
Software significant change-performance
(a) the original performance
NBOG 2014-3
1. Does the design change affect the indications or contraindications for use or
warnings necessary to ensure performance for the intended use of the device?
2. Are further clinical data necessary to support performance of the altered device?
3. Do the results of a risk analysis, undertaken during the design verification and
validation process, raise new issues of performance?
4. Does the change affect the performance of the medical device?
In cases where the change consists only of tightening of design specifications within
specified tolerances and where there is no creation of new features, the change is
not considered to be substantial
8. 8antonio.bartolozzi@bartolozzi.it
Examples
Feature Value Tollerance Giustification
Max GUI
Response Time
< 9 Seconds ± 1s See Robert B Miller 1968;
Card et al. 1991
Password lenght
(security)
> 15
characters
0 See guideline XXXX
Boot time < 20 seconds ± 1s Intended Env. : no intensive
care rooms
9. 9antonio.bartolozzi@bartolozzi.it
Software significant change - Safety
NBOG 2014-3
1. Does the design change affect the indications or contraindications for use or
warnings necessary to ensure safety for the intended use of the device?
2. Are further clinical data necessary to support safety of the altered device?
3. Do the results of a risk analysis, undertaken during the design verification and
validation process, raise new issues of safety?
4. Does the change affect the safety of the medical device?
In cases where the change consists only of tightening of design specifications within
specified tolerances and where there is no creation of new features, the change is
not considered to be substantial
(b1) the safety of the
software;
12. 12antonio.bartolozzi@bartolozzi.it
Software significant change – Intended use
NBOG 2014-3
(b1) the intended use of the
software;
• Changes of the intended purpose
• Are new hazards introduced which have not previously been addressed?
• Does the change alter the details on intended use given in the design/type approval
dossier submitted to the Notified Body?
• Does the change trigger a need to alter the indications or contraindications for use or
warnings necessary to ensure safety and efficacy for the intended use of the device?
• Does the change mean that the device will have different end users or be used in a
different manner?
• Does the change mean that the clinical data/performance evaluation data for the original
device is not sufficient to assure conformity of the changed device with the required
characteristics and performance?
14. 14antonio.bartolozzi@bartolozzi.it
Example
The Vista System is intended for use in facilities that are automating the process
associated with managing donor information, including information about blood
collection and manufacture of blood components, with the following functions:
• Managing donor data such as blood loss history , donor vital signs relevant to
blood collection, and demographics
• Storing and reporting device-connected and manually entered collection procedure
information
• Determining donor eligibility by considering donor blood loss history , user-
configured eligibility parameters, and immediate safety qualifications
• Interfacing with the Trima® Accel Automated Blood Collection System
• Aiding in the management of these blood establishment processes:
- Trima Accel sy tem configuration management
- Periodic review of platelet count and other indicators of donor health
- Prioritization and management of blood component collection
• Exchanging data with blood establishment computer systems (BECS)
• Collecting and managing data associated with whole blood and apheresis
collection procedure
15. 15antonio.bartolozzi@bartolozzi.it
Example
Intende Use Clinical Evaluation Risks/Benefits Predicate device
managing donor
information, including
information about
blood collection and
manufacture of blood
components
ClinicalEval.doc
Cap.2
RiskAnalysis.doc
Risk 2.1
Benefit 3.1
Vista Information
System, Version 4.0
Managing donor data
such as blood loss
history , donor vital
signs relevant to
blood collection, and
demographics
ClinicalEval.doc
Cap.2
RiskAnalysis.doc
Risk 3.3 3.4 3.5
Benefit 7.1 7.2
Vista Information
System, Version 4.0
16. 16antonio.bartolozzi@bartolozzi.it
Software significant change – interpretation
NBOG 2014-3
(c) interpretation of data
a software change that impacts the way data is read or interpreted by the user, such
that the treatment or diagnosis of the patient may be altered when compared to the
previous version of the software;
a software change that impacts the way data is read or interpreted by the user, such
that the device intended medical purposes and performance may be altered when
compared to the previous version of the software;
MDR
17. 17antonio.bartolozzi@bartolozzi.it
Software significant change – interpretation
a software change that impacts the way data is read or interpreted by the user, such
that the device intended medical purposes and performance may be altered when
compared to the previous version of the software;
You must review the risk analysis/design documents after each software
change that impacts the way data is read or interpreted by the user
Review Safety and performance (see slide #8,#11,#15)
Tips #4
a change that impacts the way data is read or interpreted by the user with not
negligible risk of impacting :
a) the original performance;
b) the safety or the intended use of the software;
c) interpretation of data.
18. 18antonio.bartolozzi@bartolozzi.it
Software significant change – Modifications
Such modifications include new or modified
algorithms, database structures, operating platform,
architecture or new user interfaces or new channels
for interoperability.
NBOG 2014-3
• an alteration in software that modifies an algorithm impacting the diagnosis or the therapy delivered;
• a software change that incorporates a significant change to the operating system on which the software runs.
• a software change that modifies the appearance of the user interface with not negligible risk of impacting the
diagnosis or therapy delivered to the patient
• No indication about the database structure
Better one
• an alteration in software that modifies an algorithm impacting the device intended medical
purposes and performance;
• a software change that incorporates a significant change to the operating system on which
the software runs with not negligible risk of impacting the device intended medical
purposes and performance.
• a software change that modifies the appearance of the user interface with not negligible
risk of impacting the device intended medical purposes and performance
• No indication about the database structure ➔ Problem #2
19. 19antonio.bartolozzi@bartolozzi.it
Software significant change – Algorithm
an alteration in software that modifies an algorithm impacting
the device intended medical purposes and performance;
a software change that modifies an algorithm with not negligible risk of impacting :
a) the original performance;
b) the safety or the intended use of the software;
c) interpretation of data.
You must review the risk analysis/design documents
after each software change that modifies an algorithm
Review Safety,performance and intende use (see
slide #8,#11,#15)
Tips #5
20. 20antonio.bartolozzi@bartolozzi.it
Software significant change – OS
a software change that incorporates a significant change to the
operating system on which the software runs with not negligible
risk of impacting the device intended medical purposes and
performance
a change to the operating system (on which the medical device
software runs) with not negligible risk of impacting :
a) the original performance;
b) the safety or the intended use of the software;
c) interpretation of data.
WARNING : A
minor change
in OS could
have a
significant
impact on the
safe of MD !!!
You must review the risk analysis/design documents after each
change to the OS
Review Safety,performance and intende use (see slide #8,#11,#15)
Tips #6
21. 21antonio.bartolozzi@bartolozzi.it
Software significant change – UI
a software change that modifies the appearance of the user interface with not
negligible risk of impacting the device intended medical purposes and
performance
a software change that modifies the appearance of the user interface with not
negligible risk of impacting :
a) the original performance;
b) the safety or the intended use of the software;
c) interpretation of data.
Tips #7
You must review the risk analysis/design documents
after each change to the UI
Review Safety and performance (see slide
#8,#11,#15)
22. 22antonio.bartolozzi@bartolozzi.it
Software significant change – Database
… Such modifications include new or modified database structures
a software change that modifies the database structures with not negligible risk of
impacting :
a) the original performance;
b) the safety or the intended use of the software;
c) interpretation of data.
Tips #8
You must review the risk analysis/design documents
after each change to the database
Review Safety,performance and intende use (see
slide #8,#11,#15)
23. 23antonio.bartolozzi@bartolozzi.it
Are there Minor (not significant) changes?
Example : new non-medical features
Segregated software architecture
Segregated clinical software item
new non-medical features in
“non-clinical” software item Not significant
software change
Tips #9
a software change with negligible
risk of impacting :
a) the original performance;
b) the safety;
24. 24antonio.bartolozzi@bartolozzi.it
Are there Minor (not significant) changes?
Example : new non-medical features
Not Segregated software architecture
MDR
new non-medical features
a software change with not negligible
risk of impacting :
a) the original performance;
b) the safety;
there is a modification that changes:
(a) the original performance;
(b) the safety
Significant changes
25. 25antonio.bartolozzi@bartolozzi.it
WARNING : Divide et Impera
Segregation is at first a risk
mitigation action based on software
architecture.
Software Items can detect and correct each error “near
their origin”, instead of letting it propagate through the
whole application !
Without software segregation you must review all technical
documentation after any minor software change !!!!!!!!!!!!
Problem #3
26. 26antonio.bartolozzi@bartolozzi.it
Conclusion
NBOG’s Best Practice Guide 2014-3 is it a good guide also for MDR
(with discernment).
Please consider adding/changing the following topics :
• Security
• Database structure changes
• OS changes
• The MDD concept «impacting the diagnosis or therapy
delivered to the patient» is too limited (a more aligned way with
the MDR of saying it would be «impacting the medical purposes
and performance of the device»)
Please, review the risk analysis/design documents after each significant
change to the software
Review Safety, performance and intende use (see slide #8,#11,#15)
27. 27antonio.bartolozzi@bartolozzi.it
Conclusion - Warning
Without software
segregation all core
software changes
are nearly always
significant!
Please, design it …. Design it …. And again design it
Final Tips
For any further clarification or question, please write me at
antonio.bartolozzi@bartolozzi.it