Flick through the PPT and watch a recording of Intland Software's Experts Talk webinar on 13 Nov 2019 and watch the recording at: https://intland.com/on-demand-webinar/experts-talk-balancing-innovation-risks-and-compliance-in-medical-device-development-2/
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13 Nov 2019 - Experts Talk: Balancing Innovation, Risks, and Compliance in Medical Device Development
1. 13/11/2019
Balancing Innovation, Risks and
Compliance in Medical Device
Software Development
Szabolcs Agai
Quality and Regulatory Expert
Intland Professional Services
3. 3
Webinar
info
• Q&A at the end
• Access the recording at
https://intland.com/webinar-recordings/
• 27 Nov 2019: Experts Talk: Integrated MedTech Delivery
from Requirements through Design to Quality
Documentation
Sign up at https://intland.com/webinars-events/
4. 4
• Company founded in 1998,
HQ in Stuttgart, Germany
• Active in safety-critical markets
for over 10 years
• Products and processes
certified by TÜV Nord and TÜV Süd
Who we are
Intland Software &
Medical Device Developers
7. 7
Challenges
Current landscape: Point solutions for Design Control
Task Management
Document Sharing
Requirements Management
QMS
Documents
Management
Wiki
MS Word
10. 10
Medical Software Engineering Template
Process approach
Validated,
pre-built
process templates
• Medical Software Engineering
• Medical Audit and
CAPA management
Custom tailoring • Additional and Custom Use Cases
11. 11
Our Medical Templates
support the development of
US FDA:
Software as a Medical Device (SaMD)
EU:
Medical Device Software (MDSW)
12. 12
Medical Software Engineering Template
Values
Supports your
focus on
patient safety
Saves time to
deliver
safe and effective
medical devices
Minimizes the effort spent on
administrative tasks
Enables consistent
device design content
for regulatory purposes
24. 24
• Easier definition of lifecycle-wide verification and
validation processes for simplified compliance
• IEC 82304, IEC 62304 (up to Class C) and ISO
14971 compliance support
• Product Risk Management to analyze and
evaluate risks & to maintain your Risk
Management file
• One-click traceability: handle all traceability issues
along the product lifecycle
• Integrated support and defect management
• Medical Audit and CAPA Template for ISO 13485
or FDA 21 CFR Part 820-compliant QMS
implementation
TODO:
Keresni számokat softwares eszkozok megjelenésre
How to achive that:
Innovation -> Minimum measures, that still enables highly creative work
Research -> More thinking on patient safety from the clinical risks prospective
Development -> Applying market regulation and standardization measures -> Limited chance to market otherwise
Production -> Consistency in manufacturing to preserve safety characteristics
Key Challenges
How to set measures that still enable the work to be accomplished for these phases
How to ensure, that activities follow those measures on a timely manner
How to identify and to reduce non value added activities
How to still remain quick on market access/approval
(---
Speciality for medical software -> production has a reduced scope (CD writing, delivering by updates, etc.)
Speciality for medical software -> prone to systematic errors, if there is an error, it survives with no regard to time, does not age at all.
For all medical devices -> Patient safety is first
Measures in medical devices:
Market regulations, (US) 21CFR820 + other CFRs by device type, (EU) MDR / IVDR
Standardization, ISO62304, ISO82304, ISO14971
, ISO60601-X, etc.
State of the art approaches
The typical journey of medical device development (phases):
From small scale innovations,
To more intense researches that generates more innovations on a cyclical manner,
To development that is dominated by product engineering to design medical device for mass/serial production on a reproducible, maintainable manner,
To mass/serial production.
---)
Intland -> Tooling solutions to enable medical compliance on a timely and effective manner
Landscape for medical software engineering
Generic safety standard
61508
Generic IT and software engineering standards
12207, 90003
Generic Medical process standards
13485, 14971
Med and Health SW specific process standards
62304, 82304
62366
Electric MED Product standards
60601-x
Electric equipment for measurements, control and laboratory use
61010
61010-x
Key ones to mention:
62304, 14971
82304
Kind of „usual” tooling to resolve medical engineering and regulatory challenges
Key points:
- Full traceability
- Effort to keep all these up to date
- Effort to keep all these integrated if possible at all
- Total Cost of ownership-maintenance
Organizational challenges
Streamline cooperation of the Engineering and QAR teams
Get more value out of these synergies by:
Share information on a timely manner,
Ensure consistency and authenticity of the information we have,
Work with information rather than with data stored in office documents or in island information systems.
Merging practises to common platform.
We have a NEW tool solution for all of these, called Intland Retina.
It is new common, integrated, easily accessible ALM platform with eQMS capabilities.
All software development teams in all key industries can benefit from Intland Retina.
To serve the needs of the Medical Device Software developers facing regulatory challenges, we have created process templates.
Two key implementation approach for Intland Retina
Why … Custom vs Template approach
Primary medical devices where Retina can help
Template -> Pre-configured medical industry ALM solution
Values
Save time to value added activities
Focus on patient safety
Reduce administrative tasks
Rethink the workflows you have
Integration platform components.
How do we do it.
Key aspects to design ALM application.
Can be done by user customization, can be by the Template or by the modification of the template.
Core integration to Product Risk Management.
Information containers,
Can be done by user customization, can be by the Template or by the modification of the template.
The Retina approach is an out of the box integrated approach for Product Risk management.
It includes:
Integrated by design with Requirement engineering
Integrated by design with taks and issue management
Integrated by design with verification and validation
Integrated by design with source code traceability.
No need for connectors, integration work, etc., it is designed to be genuinely integrated with all components of the Template.
It is part of the platform.
From ISO14971
Key points:
It is HARA driven approach, focusing on clinic risks, patient safety
Common confusion, it is FMEA.
FMEA is focusing on failure modes of components in the context of the next foreseeable effect.
Usual suspect for focusing on FMEA: Risk assessment is retrospective, happens when the design is more or less complete.
FMEA target is failure mode with next line of effect, HARA target is patient safety.
Any approach could be useful, may be mixture of many like FTA, ETA, HAZOP, FMEA, etc.
HARA key contents
Easier compliance for Medtech oftware development (stand-alone software, software as part of an embedded system or software as a mobile medical application) in order to define the software verification and validation processes during the entire lifecycle.
In General terms, the standards requirements of (IEC 82304, IEC 62304 and ISO 14971) are fulfilled.
The MED SW ENG template can be tailored to the reference model according to the IEC62304 classifications, it supports only the Class C.Imrovement Areas:
ISO 14971 is fully supported the Risk Management File could be created by uploaded documents. Risk analysis and evaluation is assured by the “Product Risk Management” module.
One click traceability: handle all traceability issues along the product lifecycle.
Integrated support and defect management is a big advantage.
The Medical Audit and CAPA template efficiently support the implementation of QMS based on ISO 13485 or FDA 21 CFR Part 820.
All process is traceable in the Template
Presets provided