Medical Devices Services2019-10-28T14:26:15+00:00

MEDICAL DEVICE REGULATIONS ARE HERE

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WHY CHOOSE PROCORRE?

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GETTING PRODUCTS TO MARKET / OUTSOURCED SOLUTIONS

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PROJECT TESTIMONIALS

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WHY CHOOSE PROCORRE?

The Medical Devices sector is changing as we know it. With the heightened scrutiny of Notified Bodies, significant changes being enforced through ISO 13485:2016 and the MDR and IVDR regulations, the pressure on small to medium sized medical device businesses has never been so high.
At Procorre, we are bringing together our extensive industry knowledge and access to Medical Device experts to help organisations like you comply with these changes. Our services are unparalleled and tailored to your particular needs, we provide gap analyses and assessments to ensure that you know exactly what assistance you require.

WHY CHOOSE PROCORRE?
The Medical Devices sector is changing as we know it. With the heightened scrutiny of Notified Bodies, significant changes being enforced through ISO 13485:2016 and the MDR and IVDR regulations, the pressure on small to medium sized medical device businesses has never been so high.
At Procorre, we are bringing together our extensive industry knowledge and access to Medical Device experts to help organisations like you comply with these changes. Our services are unparalleled and tailored to your particular needs, we provide gap analyses and assessments to ensure that you know exactly what assistance you require.
“At Procorre we have a large pool of specialists allowing us to offer a much more cohesive approach to projects”
Paul Fletcher-Dyer, Medical Project Services
Medical Device Report

GETTING PRODUCTS TO MARKET / OUTSOURCED SOLUTIONS

Our expansive outsourced service offering is provided through a single point of contact.
When working with one of our dedicated Medical Device Project Directors and Consultants, we can provide:
  • Technical Documentation – Including construction, review and management
  • Quality Assurance – All quality management system components, ISO:13485 compliance
  • Regulatory Affairs – international compliance support (FDA, EU), documentation review, NB submission, Internal/supplier audits, MDSAP, MDR Transition
  • Commercial Strategy – NHS contract strategy, health economics, market research
  • Marketing Strategy – international marketing strategy, clinical report writing, copywriting
Our comprehensive service offering is one of the many reasons why businesses are seeking support from Procorre.

GETTING PRODUCTS TO MARKET / OUTSOURCED SOLUTIONS

Our expansive outsourced service offering is provided through a single point of contact.
When working with one of our dedicated Medical Device Project Directors and Consultants, we can provide:
  • Technical Documentation – Including construction, review and management
  • Quality Assurance – All quality management system components, ISO:13485 compliance
  • Regulatory Affairs – international compliance support (FDA, EU), documentation review, NB submission, Internal/supplier audits, MDSAP, MDR Transition
  • Commercial Strategy – NHS contract strategy, health economics, market research
  • Marketing Strategy – international marketing strategy, clinical report writing, copywriting
Our comprehensive service offering is one of the many reasons why businesses are seeking support from Procorre.

PROJECT TESTIMONIALS

Thor Logo
“By instructing Procorre we have been able to have a thorough analysis of our products to identify any current or potential compliance issues as new regulations are being bought in within different countries.  The team have really helped us to ensure this process has been undertaken smoothly and efficiently which has helped us to focus our efforts on growing the business and operating in more and more countries, so we can help more patients in pain. We would highly recommend working with Procorre.”
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“The reclassification of our products has had an enormous effect on our business. The way we were previously working was making the business unsustainable and we were flooded with paperwork and complications which were taking a lot of time and money to resolve. I will be eternally grateful to Procorre for helping us to achieve the right compliance level and standards for our business. They helped us to cut through the jargon and set us on a path which is much easier to maintain and ensure we remain compliant in the future.”
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Biomin2
“Procorre approached us at a key time for the company and gave us the expert steer, help and advice we needed. We didn’t have that level of expertise in house, so we chose to work with them because of the competencies of the team which would undertake the project and their broad experience of similar projects. Getting the right advice and support is key in helping to market products such as ours and I wouldn’t hesitate to work with Procorre again.”
Read More

PROJECT TESTIMONIALS

Thor Logo
“By instructing Procorre we have been able to have a thorough analysis of our products to identify any current or potential compliance issues as new regulations are being bought in within different countries.  The team have really helped us to ensure this process has been undertaken smoothly and efficiently which has helped us to focus our efforts on growing the business and operating in more and more countries, so we can help more patients in pain. We would highly recommend working with Procorre.”
Read More
“The reclassification of our products has had an enormous effect on our business. The way we were previously working was making the business unsustainable and we were flooded with paperwork and complications which were taking a lot of time and money to resolve. I will be eternally grateful to Procorre for helping us to achieve the right compliance level and standards for our business. They helped us to cut through the jargon and set us on a path which is much easier to maintain and ensure we remain compliant in the future.”
Read More
Biomin2
“Procorre approached us at a key time for the company and gave us the expert steer, help and advice we needed. We didn’t have that level of expertise in house, so we chose to work with them because of the competencies of the team which would undertake the project and their broad experience of similar projects. Getting the right advice and support is key in helping to market products such as ours and I wouldn’t hesitate to work with Procorre again.”
Read More

OUR TEAM

Anne Odonnell Procorre CEO

Anne O’Donnell

Chief Executive
Officer

Anne has the ultimate responsibility for driving Procorre’s growth and success. Since co-founding the company in 2014, she has been instrumental in its expansion.

Matthew O’Donnell

Head of Partner
Development

Matthew O’Donnell discovers cutting-edge technology and builds B2B relationships to deliver our medical device projects to the highest standards.

Paul Fletcher-Dyer

Medical Devices
Partner

Paul is a dedicated, innovative Quality Assurance and Regulatory Affairs expert with 16 years’ experience in the industry. 

Andrew Chesters

Client Partner – Medical Division

Andrew’s role is to engage and meet with current and prospective clients to offer specialist consultancy and project support within the medical and medical device industries.

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CONTACT US

We are dedicated to collaborating with your business through whatever challenges you may face as we navigate through this volatile market together.
To ensure ease as you seek assistance, we offer a free consultation with our Medical Device team, here we will listen to your particular requirements and weigh up the appropriate support to ensure you achieve compliance.
For a consultation, simply fill out the form below.
Get in touch

United Kingdom
Amadeus House
27b Floral Street
London 
WC2E 9DP
+44 20 3432 0480

Switzerland
Rue du Clos 21
1st Floor
Genève 1207
+41 43 508 38 00

Singapore
#08-61 Vertex
33 Ubi Avenue 3
408868
+65 3158 7777