REGULATORY REVIEW & COMPLIANCE STRATEGY
REGULATORY REVIEW & COMPLIANCE STRATEGY
REGULATORY REVIEW & COMPLIANCE STRATEGY
Fitness for purpose in highly regulated sectors
Fitness for purpose in highly regulated sectors
Fitness for purpose in highly regulated sectors
Our team have extensive experience of developing Class 1 and 2 medical devices for sale in the UK, Europe and the US. We are also familiar with general product saftey legislation and the machinery directive.
We can advise on classification and compliance and, through our extended network, we can help put in place quality management systems and prepare documentation packs for review and submission.
Our team have extensive experience of developing Class 1 and 2 medical devices for sale in the UK, Europe and the US. We are also familiar with general product saftey legislation and the machinery directive.
We can advise on classification and compliance and, through our extended network, we can help put in place quality management systems and prepare documentation packs for review and submission.
Our team have extensive experience of developing Class 1 and 2 medical devices for sale in the UK, Europe and the US. We are also familiar with general product saftey legislation and the machinery directive.
We can advise on classification and compliance and, through our extended network, we can help put in place quality management systems and prepare documentation packs for review and submission.
Ensure your product complies with relevant legislation and standards in your target market
Design for compliance, a key part of the process.
Designing products and managing product documentation to meet the essential requirements of relevant standards is the key succsesful product development in highly regulated sectors.
Compliant by design
Accelerated time to market
Facilitates ongoing performance monitoring
Our Comprehensive Commercialisation Pathway
02.
Can I make it?
We reconcile use-cases, required performance criteria, design inputs, intended purpose etc. and draft a validation matrix against which to test and confirm that a new product or prototype is performing as expected and will do what the client expects.
04.
How can I gain an advantage?
Commercial advantage comes from having a differentiated product that people will buy. It needs appropriate strategic protection of your intellectual property and plenty of validation and testimonials that it does what it claims, backed up by outstanding product knowledge and customer service.
02.
Can I make it?
We reconcile use-cases, required performance criteria, design inputs, intended purpose etc. and draft a validation matrix against which to test and confirm that a new product or prototype is performing as expected and will do what the client expects.
04.
How can I gain an advantage?
Commercial advantage comes from having a differentiated product that people will buy. It needs appropriate strategic protection of your intellectual property and plenty of validation and testimonials that it does what it claims, backed up by outstanding product knowledge and customer service.
02.
Can I make it?
We reconcile use-cases, required performance criteria, design inputs, intended purpose etc. and draft a validation matrix against which to test and confirm that a new product or prototype is performing as expected and will do what the client expects.
04.
How can I gain an advantage?
Commercial advantage comes from having a differentiated product that people will buy. It needs appropriate strategic protection of your intellectual property and plenty of validation and testimonials that it does what it claims, backed up by outstanding product knowledge and customer service.
OUR APPROACH
OUR APPROACH
Commercialisation
Pathway ©
Can I make it?
Design for manufacture
Transfer to manufacture
Warranties
Licenses
Supply Chain
Offshore vs Onshore
Compliance
Can I make it?
Design for manufacture
Transfer to manufacture
Warranties
Licenses
Supply Chain
Offshore vs Onshore
Compliance
Can I make it?
Design for manufacture
Transfer to manufacture
Warranties
Licenses
Supply Chain
Offshore vs Onshore
Compliance
Will it work?
Testing & Validation
Noninferiority against estabilished technologies
Robustness for use case
Additional feature requirements
Will it work?
Testing & Validation
Noninferiority against estabilished technologies
Robustness for use case
Additional feature requirements
Will it work?
Testing & Validation
Noninferiority against estabilished technologies
Robustness for use case
Additional feature requirements
Will people buy it?
Commercial landscape
User Expectations
User Insights
Customer Discovery
Value Proposition
Will people buy it?
Commercial landscape
User Expectations
User Insights
Customer Discovery
Value Proposition
Will people buy it?
Commercial landscape
User Expectations
User Insights
Customer Discovery
Value Proposition
How can I gain an advantage?
IP Validation
Patents and Trademarks
Key points of differentiation
How can I gain an advantage?
IP Validation
Patents and Trademarks
Key points of differentiation
How can I gain an advantage?
IP Validation
Patents and Trademarks
Key points of differentiation
How will I fund it?
Addressable Market
Pitch Deck
Target Investors
Public / Private Sector Grants
Crowfunding Campaigns
Collaborations in Kind
How will I fund it?
Addressable Market
Pitch Deck
Target Investors
Public / Private Sector Grants
Crowfunding Campaigns
Collaborations in Kind
How will I fund it?
Addressable Market
Pitch Deck
Target Investors
Public / Private Sector Grants
Crowfunding Campaigns
Collaborations in Kind
OUR PROJECTS
OUR PROJECTS
OUR PROJECTS
Innovate faster with Crucible Innovations
Quick Block
Crucible was a sub-contractor on a DSTL (Defence Science and Technology Laboratory) funded project to develop rapidly deployable protection for use on the front line.
Our challenge was to re-design and prototype an established rapidly deployable construction solution for faster deployment, faster removal and improved ballistic protection.
Quick Block
Crucible was a sub-contractor on a DSTL (Defence Science and Technology Laboratory) funded project to develop rapidly deployable protection for use on the front line.
Our challenge was to re-design and prototype an established rapidly deployable construction solution for faster deployment, faster removal and improved ballistic protection.
Quick Block
Crucible was a sub-contractor on a DSTL (Defence Science and Technology Laboratory) funded project to develop rapidly deployable protection for use on the front line.
Our challenge was to re-design and prototype an established rapidly deployable construction solution for faster deployment, faster removal and improved ballistic protection.
Active Needle
Active Needle was founded by RSE Enterprise Fellow Muhammad Sadiq to commercialise his ultrasound guided needle visualisation technology for biopsy and regional anaesthesia developed during his PhD at the University of Dundee.
We worked with Muhammad to help him refine his business plan and financial model and to develop his value proposition and investment pitch.
Active Needle
Active Needle was founded by RSE Enterprise Fellow Muhammad Sadiq to commercialise his ultrasound guided needle visualisation technology for biopsy and regional anaesthesia developed during his PhD at the University of Dundee.
We worked with Muhammad to help him refine his business plan and financial model and to develop his value proposition and investment pitch.
Active Needle
Active Needle was founded by RSE Enterprise Fellow Muhammad Sadiq to commercialise his ultrasound guided needle visualisation technology for biopsy and regional anaesthesia developed during his PhD at the University of Dundee.
We worked with Muhammad to help him refine his business plan and financial model and to develop his value proposition and investment pitch.
Visual Fixation System
Provide a Visual Fixation solution that allows an Optometrist the ability to capture and hold a patient's gaze.
The product will primarily be focused for use on patients with learning disabilities or autism.
Visual Fixation System
Provide a Visual Fixation solution that allows an Optometrist the ability to capture and hold a patient's gaze.
The product will primarily be focused for use on patients with learning disabilities or autism.
Visual Fixation System
Provide a Visual Fixation solution that allows an Optometrist the ability to capture and hold a patient's gaze.
The product will primarily be focused for use on patients with learning disabilities or autism.
Step Sense
Step sense is an AI software solution designed to interpret gait from video files and signpost metrics to diagnose, manage and monitor chronic musculoskeletal and neurological conditions.
The challenge was to develop an investable proposition in the context of technology, applications, and the market.
Step Sense
Step sense is an AI software solution designed to interpret gait from video files and signpost metrics to diagnose, manage and monitor chronic musculoskeletal and neurological conditions.
The challenge was to develop an investable proposition in the context of technology, applications, and the market.
Step Sense
Step sense is an AI software solution designed to interpret gait from video files and signpost metrics to diagnose, manage and monitor chronic musculoskeletal and neurological conditions.
The challenge was to develop an investable proposition in the context of technology, applications, and the market.
Retinal Imaging Densitometer
The prototype retinal imaging densitometer was developed by Prof. Tom Margrain at Cardiff University and the UK Astronomy Technology Centre in Edinburgh.
It uses optical analysis technology developed for use in space to image metabolic reactions in the back of eye at a cellular level.
Retinal Imaging Densitometer
The prototype retinal imaging densitometer was developed by Prof. Tom Margrain at Cardiff University and the UK Astronomy Technology Centre in Edinburgh.
It uses optical analysis technology developed for use in space to image metabolic reactions in the back of eye at a cellular level.
Retinal Imaging Densitometer
The prototype retinal imaging densitometer was developed by Prof. Tom Margrain at Cardiff University and the UK Astronomy Technology Centre in Edinburgh.
It uses optical analysis technology developed for use in space to image metabolic reactions in the back of eye at a cellular level.
Crucible Compactor
An innovative solution developed to enhance waste management efficiency, combines cutting-edge technology with practical design.
Crucible Compactor
An innovative solution developed to enhance waste management efficiency, combines cutting-edge technology with practical design.
Crucible Compactor
An innovative solution developed to enhance waste management efficiency, combines cutting-edge technology with practical design.
FAQ
FAQ
FAQ
We've got all the answers
What services does Crucible Innovations offer?
Crucible innovations offers a focused range of services to ensure your product is fit for purpose by design, targeted to a receptive market and successfully comercialised.
How do you ensure the commercial viability of a product?
What is your approach to sustainable design?
Can you help with brand identity and strategy?
What prototyping techniques do you use?
How do you ensure a product is fit for purpose?
What services does Crucible Innovations offer?
Crucible innovations offers a focused range of services to ensure your product is fit for purpose by design, targeted to a receptive market and successfully comercialised.
How do you ensure the commercial viability of a product?
What is your approach to sustainable design?
Can you help with brand identity and strategy?
What prototyping techniques do you use?
How do you ensure a product is fit for purpose?
What services does Crucible Innovations offer?
Crucible innovations offers a focused range of services to ensure your product is fit for purpose by design, targeted to a receptive market and successfully comercialised.
How do you ensure the commercial viability of a product?
What is your approach to sustainable design?
Can you help with brand identity and strategy?
What prototyping techniques do you use?
How do you ensure a product is fit for purpose?