Medical Devices Outsourcing Services – Procorre2019-12-04T09:13:14+00:00

BRINGING MEDICAL DEVICES TO MARKET

SIMPLIFYING MEDICAL INNOVATION

In an ever-changing industry, medical device manufacturers are continuously challenged with meeting the latest legislative changes to ensure they can bring their products into new markets, and retain them in existing ones.

From global marketing strategy and health economics through to technical file management, quality assurance / regulatory affairs to all major global market standards, our dedicated medical division work closely with organisations who are bringing products to market and preparing for the Medical Device Regulation (MDR).

Realigning Your Goals

Our support aims to allow clients to alleviate concerns around  regulatory and quality functions, and shift more focus onto their core aims as a business, leading to more profitability and growth.

Medical Device Regulation (MDR) Planning

Get ready for MDR with our comprehensive medical devices outsourcing services. We offer a tailored 2-day training workshop with one of our dedicated medical device project directors, which covers training, mapping and transition work planning for MDR.

If you’re looking to enhance your current business processes or would like to discuss your preparations for the ever-changing medical landscape, let’s talk.

SPEAK TO OUR MEDICAL DEVICE EXPERTS

In an ever-changing industry, medical device manufacturers are continuously challenged with meeting the latest legislative changes to ensure they can bring their products into new markets, and retain them in existing ones.

From global marketing strategy and health economics through to technical file management, quality assurance / regulatory affairs to all major global market standards, our dedicated medical division work closely with organisations who are bringing products to market and preparing for the Medical Device Regulation (MDR).

Prepare for MDR with our medical devices outsourcing services. We also offer a tailored 2-day training workshop with one of our dedicated medical device project directors, which covers training, mapping and transition work planning for MDR.

If you’re looking to enhance your current business processes or would like to discuss your preparations for the ever-changing medical landscape, let’s talk.

SPEAK TO OUR MEDICAL DEVICE EXPERTS

OUR MEDICAL DEVICE OFFERING

Commercial Strategy

Our experience of working within the industry means that we can provide an NHS contract strategy, health economics and market/viability research. We can also offer invaluable advice on the importing and exporting of devices.

Regulatory Affairs

We can provide international compliance support (including FDA, EU and more), MDR transition support, documentation reviews, Notified Body submissions, internal/supplier audits, and MDSAP services.

Technical Documentation

We can help with a variety of stages of technical documentation requirements, including the construction, management, review, and remediation.

Quality Assurance

We offer a fully outsourced solution which encompasses quality management system component support, comprehensive ISO:13485 compliance and more.

Risk Management

We can provide ISO:14971 risk management for medical devices, including providing support with compliance around the Medical Device Regulation (MDR).

Marketing Strategy

We offer a number of international marketing strategy services including clinical report writing, copywriting, advertising and more.

OUR MEDICAL DEVICE OFFERING

Commercial Strategy

Our experience of working within the industry means that we can provide an NHS contract strategy, health economics and market/viability research. We can also offer invaluable advice on the importing and exporting of devices.

Regulatory Affairs

We can provide international compliance support (including FDA, EU and more), MDR transition support, documentation reviews, Notified Body submissions, internal/supplier audits, and MDSAP services.

Technical Documentation

We take significant measures to protect organizations with adequate insurances and defense in the event of any legal challenges with their global expansion.

Quality Assurance

We offer a fully outsourced solution which encompasses quality management system component support, comprehensive ISO:13485 compliance and more.

Talent Management

We can provide ISO:14971 risk management for medical devices, including providing support with compliance around the Medical Device Regulation (MDR).

Marketing Strategy

We offer a number of international marketing strategy services including clinical report writing, copywriting, advertising and more.

MEDICAL DEVICE CHALLENGES

Ensuring Product Quality

Regulatory Compliance (Most Notably MDR)

Globalisation of Medical Devices

Notified Bodies and Brexit

Cost of Product Development

*Statistics from infinitiresearch.com

MEDICAL DEVICE CHALLENGES

  • Ensuring Product Quality
  • Regulatory Compliance (Most Notably MDR)
  • Localisation of Medical Devices
  • Notified Bodies and Brexit
  • Cost of Product Development
  • *Statistics from infinitiresearch.com

MEDICAL DEVICE RESOURCES

Medical Devices Blog

Blogs and News

Our Medical Device Project Directors and Partners have put together a number of blogs sharing their thoughts on the industry. Explore our library of Medical Device Blogs and News today.

READ MORE
Medical Devices Offering

Our Services Offering

Download our full services offering document to learn how we can help you to enhance your business processes and bring devices to market.

DOWNLOAD
Medical Devices Whitepaper

ISO: 13485 Whitepaper

Bringing together extensive research and knowledge from our team, learn all about the cahnges to ISO13485 / MDD and IVD Directives.

DOWNLOAD

MEDICAL DEVICE RESOURCES

Medical Devices Blog

Blogs and News

Our Medical Device Project Directors and Partners have put together a number of blogs sharing their thoughts on the industry. Explore our library of Medical Device Blogs and News today.

READ MORE
Medical Devices Offering

Our Services Offering

Download our full services offering document to learn how we can help you to enhance your business processes and bring devices to market.

DOWNLOAD
Medical Devices Whitepaper

ISO: 13485 Whitepaper

Bringing together extensive research and knowledge from our team, learn all about the cahnges to ISO13485 / MDD and IVD Directives.

DOWNLOAD

WHY PROCORRE?

As a global consultancy with a focus on delivering the best services to our clients, we are trusted to deliver numerous successful medical devices outsourcing projects every year. Our dedicated health division, with a team of expert consultants in the medical device industry is headed by Preeti Choudhary and Paul Fletcher-Dyer.

When collaborating with Procorre to deliver your requirements, you will receive a single point of contact through a solution for all or some of your medical devices, outsourcing quality assurance / regulatory affairs.

Procorre Global Consultancy
Procorre Global Reach

Why Procorre?

As a global consultancy with a focus on delivering the best services to our clients, we are trusted to deliver numerous successful medical devices outsourcing projects every year. Our dedicated health division, with a team of expert consultants in the medical device industry is headed by Preeti Choudhary and Paul Fletcher-Dyer.

When collaborating with Procorre to deliver your requirements, you will receive a single point of contact through a solution for all or some of your medical devices, outsourcing quality assurance / regulatory affairs.

“We operate very successfully throughout the world; however, we only have a small team of 20 people working for us. By instructing Procorre we have been able to have a through 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.”

Harvie Ward, Senior Design and Development Engineer, Thor

“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.”

Bill Wilson, Owner, Jack Allen

“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.”

Richard Whatley, CEO, BioMin Technologies

“We operate very successfully throughout the world; however, we only have a small team of 20 people working for us. By instructing Procorre we have been able to have a through 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.”

Harvie Ward, Senior Design and Development Engineer, Thor

“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.”

Bill Wilson, Owner, Jack Allen

“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.”

Richard Whatley, CEO, BioMin Technologies