MedTech regulatory support
Product development with regulatory expertise and guidance for seamless compliance with global healthcare standards.
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 regulatory support
Product development with regulatory expertise and guidance for seamless compliance with global healthcare standards.
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 regulatory support
Product development with regulatory expertise and guidance for seamless compliance with global healthcare standards.
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.
What we offer
Tailored regulatory consulting and compliance support to accelerate MedTech product approvals across global markets.
Can't find what you're looking for?
With over 500 experts we are here to help.
500+
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.
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-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.
500+
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-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.
500+
What we offer
Tailored regulatory consulting and compliance support to accelerate MedTech product approvals across global markets.
Can't find what you're looking for?
With over 500 experts we are here to help.
500+
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.
How we support you
Our comprehensive approach ensures your regulatory needs are addressed at every stage, from concept to market entry.
Can't find what you're looking for?
With over 500 experts we are here to help.
500+
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.
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.
How we support you
Our comprehensive approach ensures your regulatory needs are addressed at every stage, from concept to market entry.
Can't find what you're looking for?
With over 500 experts we are here to help.
500+
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.
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.
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.
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.
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.
Can't find what you're looking for?
With over 500 experts we are here to help.
500+
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.
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.
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.
Can't find what you're looking for?
With over 500 experts we are here to help.
500+
We are over 500 world-class innovation experts, scientists and engineers.
We are over 500 world-class innovation experts, scientists and engineers.
We are over 500 world-class innovation experts, scientists and engineers.
£3 billion of private investment unlocked
R&D projects delivered
Years of experience
Business collaborations
m² of facilities
Over £220m of innovation assets
£3 billion of private investment unlocked
R&D projects delivered
Years of experience
Business collaborations
m² of facilities
Over £220m of innovation assets
£3 billion of private investment unlocked
R&D projects delivered
Years of experience
Business collaborations
m² of facilities
Over £220m of innovation assets
Trusted by leading organisations
"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
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
Let's innovate together
At CPI, we understand that every innovation, manufacturing process, and application is unique. Our flexible engagement model builds custom projects around your goals.
Cheryl Dean
MedTech regulatory support
Business Development
Get in touch
Let's innovate together
At CPI, we understand that every innovation, manufacturing process, and application is unique. Our flexible engagement model builds custom projects around your goals.
Cheryl Dean
MedTech regulatory support
Business Development
Get in touch
Let's innovate together
At CPI, we understand that every innovation, manufacturing process, and application is unique. Our flexible engagement model builds custom projects around your goals.
Cheryl Dean
MedTech regulatory support
Business Development
