MedTech

MedTech regulatory support

Product development with regulatory expertise and guidance for seamless compliance with global healthcare standards.

Get in touch

View capabilities

Navigating the complexities of healthcare regulations is crucial for bringing new products to market

At CPI, we specialise in supporting the design and development of your products and processes with meeting regulatory requirements at the forefront. 

Our tailored approach ensures your MedTech innovations are developed in alignment with evolving international standards and regulations, to faster achieve UKCA, CE, and FDA certification. We will guide you step by step, helping you advance your technologies with confidence.

CPI expert engaging in a consultation with a client.

MedTech

MedTech regulatory support

Product development with regulatory expertise and guidance for seamless compliance with global healthcare standards.

Get in touch

View capabilities

Navigating the complexities of healthcare regulations is crucial for bringing new products to market

At CPI, we specialise in supporting the design and development of your products and processes with meeting regulatory requirements at the forefront. 

Our tailored approach ensures your MedTech innovations are developed in alignment with evolving international standards and regulations, to faster achieve UKCA, CE, and FDA certification. We will guide you step by step, helping you advance your technologies with confidence.

MedTech

MedTech regulatory support

Product development with regulatory expertise and guidance for seamless compliance with global healthcare standards.

Get in touch

View capabilities

Navigating the complexities of healthcare regulations is crucial for bringing new products to market

At CPI, we specialise in supporting the design and development of your products and processes with meeting regulatory requirements at the forefront. 

Our tailored approach ensures your MedTech innovations are developed in alignment with evolving international standards and regulations, to faster achieve UKCA, CE, and FDA certification. We will guide you step by step, helping you advance your technologies with confidence.

CPI expert engaging in a consultation with a client.
  • Stream Bio
  • Touchlight Genetics
  • JUNE logo with the tagline.
  • NeoBand
  • Ventus Medical
  • Stream Bio
  • Touchlight Genetics
  • JUNE logo with the tagline.
  • NeoBand
  • Ventus Medical

What we offer

Tailored regulatory consulting and compliance support to accelerate MedTech product approvals across global markets.

What we offer

Tailored regulatory consulting and compliance support to accelerate MedTech product approvals across global markets.

What we offer

Tailored regulatory consulting and compliance support to accelerate MedTech product approvals across global markets.

Regulatory strategy consultancy

Navigate complex regulatory requirements with confidence. Our tailored guidance helps you align your innovation with global standards and regulations, ensuring compliance and increasing your chances of successful certification.

Regulatory strategy consultancy

Navigate complex regulatory requirements with confidence. Our tailored guidance helps you align your innovation with global standards and regulations, ensuring compliance and increasing your chances of successful certification.

Regulatory-aligned product design and development

With CPI, seamlessly integrate regulatory considerations into your product design and development. Our expertise and ISO13485 accreditation ensure your innovations align with global regulations such as UKCA, CE, and FDA. We help you develop robust products and processes, guiding you through critical pathways to market readiness while reducing risks and accelerating time-to-market.

Regulatory-aligned product design and development

With CPI, seamlessly integrate regulatory considerations into your product design and development. Our expertise and ISO13485 accreditation ensure your innovations align with global regulations such as UKCA, CE, and FDA. We help you develop robust products and processes, guiding you through critical pathways to market readiness while reducing risks and accelerating time-to-market.

Can’t find what you’re looking for?

With over 500 experts we are here to help.

Get in touch

Can’t find what you’re looking for?

With over 500 experts we are here to help.

Get in touch

Can’t find what you’re looking for?

With over 500 experts we are here to help.

Get in touch

How we support you

Our comprehensive approach ensures your regulatory needs are addressed at every stage, from concept to market entry.

How we support you

Our comprehensive approach ensures your regulatory needs are addressed at every stage, from concept to market entry.

How we support you

Our comprehensive approach ensures your regulatory needs are addressed at every stage, from concept to market entry.

Demonstrate form and function

Our team of experts can accelerate your product’s development with:

  • Early regulatory alignment to ensure your product development strategy facilitates successful market access.

  • Development and testing in compliance with global healthcare standards and regulations.

  • Integration of regulatory requirements into your product portfolio for a competitive advantage.

Demonstrate form and function

Our team of experts can accelerate your product’s development with:

  • Early regulatory alignment to ensure your product development strategy facilitates successful market access.

  • Development and testing in compliance with global healthcare standards and regulations.

  • Integration of regulatory requirements into your product portfolio for a competitive advantage.

Prove manufacturability and scalability

Whatever your innovation, we ensure it’s both manufacturable and compliant.

We provide:

  • Feasibility studies and prototyping to align manufacturing processes with regulatory requirements.

  • Scalable production processes that meet stringent quality and compliance standards.

  • Integrated product design and manufacturing process risk analysis under one roof to ensure product compliance throughout.

Prove manufacturability and scalability

Whatever your innovation, we ensure it’s both manufacturable and compliant.

We provide:

  • Feasibility studies and prototyping to align manufacturing processes with regulatory requirements.

  • Scalable production processes that meet stringent quality and compliance standards.

  • Integrated product design and manufacturing process risk analysis under one roof to ensure product compliance throughout.

Assess and demonstrate commercial viability

We provide the evidence and insights needed to attract investment and partnerships.

Our expertise helps:

  • Demonstrate regulatory readiness to secure funding and investment opportunities.

  • Assure product compliance with international standards to attract market partners.

  • Provide evidence of scalability and adherence to quality systems for healthcare use.

Assess and demonstrate commercial viability

We provide the evidence and insights needed to attract investment and partnerships.

Our expertise helps:

  • Demonstrate regulatory readiness to secure funding and investment opportunities.

  • Assure product compliance with international standards to attract market partners.

  • Provide evidence of scalability and adherence to quality systems for healthcare use.

Secure strategic partnerships

As a trusted UK Government partner, we connect you to the networks you need.

We enable you to:

  • Connect with trusted partners to further streamline your regulatory journey.

  • Leverage supply chains and industry networks to align production with compliance requirements.

  • Facilitate sector-wide partnerships to share challenges and opportunities and influence public stakeholders.

Secure strategic partnerships

As a trusted UK Government partner, we connect you to the networks you need.

We enable you to:

  • Connect with trusted partners to further streamline your regulatory journey.

  • Leverage supply chains and industry networks to align production with compliance requirements.

  • Facilitate sector-wide partnerships to share challenges and opportunities and influence public stakeholders.

  • Scientist in a lab coat and safety glasses operating a 3D printer producing blue printed parts.
    Pipette dispensing a red droplet into rows of small clear laboratory sample tubes.
  • CPI scientist in a lab coat and safety glasses handling sample vials in a laboratory.
    Gloved hand using a multichannel pipette to fill a microplate with pink liquid beside sample bottles.
  • Person performing a self-swab test, holding a swab and sample tube over an instruction sheet.
  • Engineer reviewing a printed circuit board design across two computer monitors at a workstation.
    Two CPI scientists in lab coats and safety glasses reviewing data on a tablet in a laboratory.
  • Close-up of a green printed circuit board being manufactured on automated production equipment.
    Gloved scientist using a pipette to add liquid to a petri dish inside a laboratory fume hood.
  • Close-up of an older person's arm fitted with a wearable monitoring device while two people adjust it.
  • Scientist in a lab coat and safety glasses operating a 3D printer producing blue printed parts.
    Pipette dispensing a red droplet into rows of small clear laboratory sample tubes.
  • CPI scientist in a lab coat and safety glasses handling sample vials in a laboratory.
    Gloved hand using a multichannel pipette to fill a microplate with pink liquid beside sample bottles.
  • Person performing a self-swab test, holding a swab and sample tube over an instruction sheet.
  • Engineer reviewing a printed circuit board design across two computer monitors at a workstation.
    Two CPI scientists in lab coats and safety glasses reviewing data on a tablet in a laboratory.
  • Close-up of a green printed circuit board being manufactured on automated production equipment.
    Gloved scientist using a pipette to add liquid to a petri dish inside a laboratory fume hood.
  • Close-up of an older person's arm fitted with a wearable monitoring device while two people adjust it.
  • Scientist in a lab coat and safety glasses operating a 3D printer producing blue printed parts.
    Pipette dispensing a red droplet into rows of small clear laboratory sample tubes.
  • CPI scientist in a lab coat and safety glasses handling sample vials in a laboratory.
    Gloved hand using a multichannel pipette to fill a microplate with pink liquid beside sample bottles.
  • Person performing a self-swab test, holding a swab and sample tube over an instruction sheet.
  • Engineer reviewing a printed circuit board design across two computer monitors at a workstation.
    Two CPI scientists in lab coats and safety glasses reviewing data on a tablet in a laboratory.
  • Close-up of a green printed circuit board being manufactured on automated production equipment.
    Gloved scientist using a pipette to add liquid to a petri dish inside a laboratory fume hood.
  • Close-up of an older person's arm fitted with a wearable monitoring device while two people adjust it.
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Trusted by leading organisations

Showing slide 1 of 1
NeoBand

I’ve worked in hospitals for years and believe that clinicians come up with lots of innovative ways to do things better. The stumbling block is getting them to come to fruition. I was looking for people to help me out, struggling, thinking this is never going to happen. CPI listened, they got it, and they’ve made it a reality.

A headshot of Helen McAdam

Helen McAdam

Co-Inventor and Co-Executive

Stream Bio

CPI accelerated our route to commercialisation by a long way, all of the work was done in CPI with access to scientists and equipment. This saved us in the region of £750K — £1m capital investment.

Andy Chaloner, CEO Stream Bio

Andy Chaloner

CEO

JUNE logo with the tagline.

CPI designed the electronics that enabled us to repackage our technology into a wearable and portable form. The collaboration has also enabled us to rigorously test all the components to meet safety standards. We can now bring this technology to more people to help with their stroke rehabilitation.

Laura Salisbury, CEO KnitRegen

Laura Salisbury

CEO

CLEWS Medical

It has been a fantastic experience working alongside CPI. For every obstacle that we’ve come across, the CPI team have been prepared to investigate and find ways around them. Although we've only made early progress along a much longer road to commercialisation, I feel confident that this road has been roughly mapped out by the knowledge and contacts provided by CPI.

Dr Michael Ross, Founder CLEWS Medical

Dr Michael Ross

Founder

Ventus Medical

CPI has played a pivotal role in the development of ENHALE, allowing us to identify the optimum materials and processes for the scalable & sustainable manufacturer of a safe and efficacious medicine.

Headshot of David Lawson, Co-Founder

David Lawson

Co-Founder

Trusted by leading organisations

Showing slide 1 of 1
NeoBand

I’ve worked in hospitals for years and believe that clinicians come up with lots of innovative ways to do things better. The stumbling block is getting them to come to fruition. I was looking for people to help me out, struggling, thinking this is never going to happen. CPI listened, they got it, and they’ve made it a reality.

A headshot of Helen McAdam

Helen McAdam

Co-Inventor and Co-Executive

Stream Bio

CPI accelerated our route to commercialisation by a long way, all of the work was done in CPI with access to scientists and equipment. This saved us in the region of £750K — £1m capital investment.

Andy Chaloner, CEO Stream Bio

Andy Chaloner

CEO

JUNE logo with the tagline.

CPI designed the electronics that enabled us to repackage our technology into a wearable and portable form. The collaboration has also enabled us to rigorously test all the components to meet safety standards. We can now bring this technology to more people to help with their stroke rehabilitation.

Laura Salisbury, CEO KnitRegen

Laura Salisbury

CEO

CLEWS Medical

It has been a fantastic experience working alongside CPI. For every obstacle that we’ve come across, the CPI team have been prepared to investigate and find ways around them. Although we've only made early progress along a much longer road to commercialisation, I feel confident that this road has been roughly mapped out by the knowledge and contacts provided by CPI.

Dr Michael Ross, Founder CLEWS Medical

Dr Michael Ross

Founder

Ventus Medical

CPI has played a pivotal role in the development of ENHALE, allowing us to identify the optimum materials and processes for the scalable & sustainable manufacturer of a safe and efficacious medicine.

Headshot of David Lawson, Co-Founder

David Lawson

Co-Founder

Trusted by leading organisations

Showing slide 1 of 1
NeoBand

I’ve worked in hospitals for years and believe that clinicians come up with lots of innovative ways to do things better. The stumbling block is getting them to come to fruition. I was looking for people to help me out, struggling, thinking this is never going to happen. CPI listened, they got it, and they’ve made it a reality.

A headshot of Helen McAdam

Helen McAdam

Co-Inventor and Co-Executive

Stream Bio

CPI accelerated our route to commercialisation by a long way, all of the work was done in CPI with access to scientists and equipment. This saved us in the region of £750K — £1m capital investment.

Andy Chaloner, CEO Stream Bio

Andy Chaloner

CEO

JUNE logo with the tagline.

CPI designed the electronics that enabled us to repackage our technology into a wearable and portable form. The collaboration has also enabled us to rigorously test all the components to meet safety standards. We can now bring this technology to more people to help with their stroke rehabilitation.

Laura Salisbury, CEO KnitRegen

Laura Salisbury

CEO

CLEWS Medical

It has been a fantastic experience working alongside CPI. For every obstacle that we’ve come across, the CPI team have been prepared to investigate and find ways around them. Although we've only made early progress along a much longer road to commercialisation, I feel confident that this road has been roughly mapped out by the knowledge and contacts provided by CPI.

Dr Michael Ross, Founder CLEWS Medical

Dr Michael Ross

Founder

Ventus Medical

CPI has played a pivotal role in the development of ENHALE, allowing us to identify the optimum materials and processes for the scalable & sustainable manufacturer of a safe and efficacious medicine.

Headshot of David Lawson, Co-Founder

David Lawson

Co-Founder

Why choose CPI?

Global regulatory experience

Familiarity with UKCA, CE, FDA and other international frameworks.

Strategic guidance

Regulatory alignment from early-stage concept through to market entry.

Risk mitigation

Design and documentation practices that avoid delays and redesign.

Quality systems expertise

ISO13485-compliant infrastructure and QMS integration support.

Cross-functional collaboration

Regulatory insights embedded within technical development workflows.

Faster approvals

Helping streamline applications and reduce barriers to entry.

Why choose CPI?

Global regulatory experience

Familiarity with UKCA, CE, FDA and other international frameworks.

Strategic guidance

Regulatory alignment from early-stage concept through to market entry.

Risk mitigation

Design and documentation practices that avoid delays and redesign.

Quality systems expertise

ISO13485-compliant infrastructure and QMS integration support.

Cross-functional collaboration

Regulatory insights embedded within technical development workflows.

Faster approvals

Helping streamline applications and reduce barriers to entry.

Why choose CPI?

Work with us to defer capital and workforce investments until your product or process is proven at scale.

Global regulatory experience

Familiarity with UKCA, CE, FDA and other international frameworks.

Strategic guidance

Regulatory alignment from early-stage concept through to market entry.

Risk mitigation

Design and documentation practices that avoid delays and redesign.

Quality systems expertise

ISO13485-compliant infrastructure and QMS integration support.

Cross-functional collaboration

Regulatory insights embedded within technical development workflows.

Faster approvals

Helping streamline applications and reduce barriers to entry.

Get in touch

Get in touch

Get in touch

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