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Free FMEA template download: Failure Modes and Effects Analysis

Free FMEA template download: Failure Modes and Effects Analysis

by Mazur, B | Last updated Aug 1, 2023 | HEALTH, INSIGHTS, REGULATORY, TEMPLATES, TOOLS

Free FMEA template download: Failure Modes and Effects Analysis  Reading time 10 mins Key Points It’s a logical and structured way to identify and prioritise areas (i.e. failure modes) that could cause a process, product, or service to fail, hinder success, or cause...
What are the key regulatory challenges of Software as a Medical Device (SaMD)?

What are the key regulatory challenges of Software as a Medical Device (SaMD)?

by Mazur, B | Last updated Nov 7, 2024 | HEALTH, INSIGHTS, Medical, REGULATORY, SOFTWARE

What are the key regulatory challenges of Software as a Medical Device (SaMD)? Reading time 15 mins Key Points There is a lack of harmonisation between different regulatory bodies (e.g. FDA, MHRA, and EU MDR) as they define and categorise SaMD differently This changes...
What is ISO 13485? Is it mandatory for medical device compliance?

What is ISO 13485? Is it mandatory for medical device compliance?

by Mazur, B | Last updated Nov 7, 2024 | HEALTH, INSIGHTS, Medical, REGULATORY

What is ISO 13485? Is it mandatory for medical device compliance? Reading time 7 mins Key Points ISO 13485 is an international standard which specifies the requirements for quality management systems (QMS) for the design, production, installation, and servicing of...
How does UK MDR (Medical Device Regulations) differ from EU MDR?

How does UK MDR (Medical Device Regulations) differ from EU MDR?

by Mazur, B | Last updated Nov 7, 2024 | HEALTH, INSIGHTS, Medical, REGULATORY

How does UK MDR (Medical Device Regulations) differ from EU MDR? Reading time 8 mins Key Points All medical devices placed on the Great Britain market (England, Scotland, Wales) need to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA)...
UK medical device regulations glossary: What every medical device engineer should know

UK medical device regulations glossary: What every medical device engineer should know

by Mazur, B | Last updated Nov 7, 2024 | Guides, HEALTH, INSIGHTS, Medical, REGULATORY

UK Medical Device Regulations (MDR) Glossary: What every medical device engineer should know Reading time 12 mins Key Points As demand for healthcare technologies increases, rushing to get products to the market by cutting corners can have serious consequences UK...
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Recent Posts

  • Energy harvesting for IoT: Custom systems that power smarter devices Last updated Nov 7, 2024
  • Why energy-efficient wellness wearables matter for scaleable health tech innovation Last updated Nov 7, 2024
  • The environmental manager’s guide to IoT water monitoring solutions Last updated Nov 7, 2024
  • The secret to scalable IoT products? PCB design and manufacturing Last updated Nov 7, 2024
  • How can agricultural robotics solutions become more accessible to farmers Last updated Nov 7, 2024
  • Gesture Recognition in Wearable Technology Last updated Nov 7, 2024
  • Designing Autonomous Underwater Vehicle Solutions Last updated Nov 7, 2024
  • Design and Manufacturing of Environmental Monitoring Technology Last updated Nov 7, 2024
  • Still testing manually? Here’s why you need a bespoke test rig Last updated Nov 7, 2024
  • Wearable device prototyping: 10 mistakes startups can’t afford to make Last updated Nov 7, 2024

Recent Posts

  • Energy harvesting for IoT: Custom systems that power smarter devices
  • Why energy-efficient wellness wearables matter for scaleable health tech innovation
  • The environmental manager’s guide to IoT water monitoring solutions
  • The secret to scalable IoT products? PCB design and manufacturing
  • How can agricultural robotics solutions become more accessible to farmers
  • Gesture Recognition in Wearable Technology
  • Designing Autonomous Underwater Vehicle Solutions

Recent Posts

  • Energy harvesting for IoT: Custom systems that power smarter devices
  • Why energy-efficient wellness wearables matter for scaleable health tech innovation
  • The environmental manager’s guide to IoT water monitoring solutions
  • The secret to scalable IoT products? PCB design and manufacturing
At Ignitec®, we transform groundbreaking ideas into impactful, market-ready products. Our innovations are shaping a healthier, safer, and more sustainable world. We’re ready to show you how.
Get in touch

ABOUT
About
Careers
Quality management
Reviews
FAQ

VERTICALS
IoT
Wearable technology
Health tech
Environmental monitoring

SOLUTIONS
Innovation on Autopilot®
Innovation on Demand®

SERVICES
Product design consultancy
Wearable technology
IoT design services
Electronic design service
Electronic prototype design
Software development service

Rapid prototyping
Mechanical engineering service
PCB design service

Product manufacturing services
Early stage technology

Research & development
Test rig design services
CAD design service
Custom enclosure design
Prototyping lab
Custom hardware
Minimum viable product
Machinery design
Rapid technology integration service
Technology demonstrator service
Product design Bristol
Low volume manufacture
Kickstarter prototype
Industrial design

CASE STUDIES
Case studies

CLIENTS
Inventors
Universities
Start-up
Scale-up
SME's
Corporates

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At Ignitec®, we transform groundbreaking ideas into impactful, market-ready products. Our innovations are shaping a healthier, safer, and more sustainable world. We’re ready to show you how.
Get in touch

ABOUT
About
Careers
Quality management
Reviews
FAQ

VERTICALS
IoT
Wearable technology
Health tech
Environmental monitoring

SOLUTIONS
Innovation on Autopilot®
Innovation on Demand®

SERVICES
Product design consultancy
Wearable technology
IoT design services
Electronic design service
Electronic prototype design
Software development service
Rapid prototyping
Mechanical engineering service
PCB design service
Product manufacturing services
Early stage technology
Research & development
Test rig design services
CAD design service
Custom enclosure design
Prototyping lab
Custom hardware
Minimum viable product
Machinery design
Rapid technology integration service
Technology demonstrator service
Product design Bristol
Low volume manufacture
Kickstarter prototype
Industrial design

CASE STUDIES
Case studies

CLIENTS
Inventors
Universities
Start-up
Scale-up
SME's
Corporates

INSIGHTS
Insights

POLICY
Cookie policy

Privacy policy
Terms of use
Sustainability policy
Equal opportunities policy
Community impact policy
Anti-bribery and corruption policy
Modern slavery policy
Quality policy
Disclaimer
Confidentiality statement
Shipping policy

  • Follow
  • Follow
  • Follow
  • Follow

Ignitec ltd is registered in England and Wales, company number 8476686. Registered office: 1 The Powerhouse, Great Park Road, Bradley Stoke, Bristol, BS32 4RU, United Kingdom. Copyright © 2013-2024 Ignitec ltd. Ignitec® and the Ignitec Hare are registered trademarks of Ignitec ltd.

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