Staffing - Medical Devices LONDON GENEVA SINGAPORE DUBLIN procorre.com 1
Implementing solutions to clients worldwide 2
Contents Services 04 Sector Overview 07 Medical Devices 07 In-Vitro Diagnostics 08 Overview of ISO13485:2016 09 Regulatory Affairs 12 Quality Assurance 14 Research & Development 16 Engineers 18 Summary 20 Contact Us 21 3
Services Procorre is a global professional services consultancy trusted to deliver experienced consultants worldwide. Partnering with Procorre will give you access to our pool of expert consultants from varied sectors and specialisms, enabling you to place the highest calibre consultants you need. We are experts in sourcing talent, global mobility and managing projects across a range of industries. We re able to offer a range of project services to manage projects from inception to completion, through the entire project life cycle. 4
Services Our teams are able to deliver a human capital management process designed for your individual needs in any country. Procorre International Project Services: Supplying consultants for projects - over 1,500 consultants deployed worldwide Access to our global network of consultants Life cycle global mobility in over 120 countries Contractor management Outsourcing options We trust that in an ever changing environment partnering with Procorre will add value to your business, reduce risk and deliver projects on time. 5
Services Having established an excellent working relationship with all the notified bodies in Europe since 1996 and as recognised world leaders in our field of expertise, Procorre are working in partnership with European Device Solutions Ltd, to offer all our global clients a complete range of services to ensure their medical and in-vitro devices are compliant with the latest standards. As recognised world leaders in our field of expertise with the medical devices industry, Procorre are looking to work with contractors in: Regulatory Affairs (page 12) Quality Assurance (page 14) Research & Development (page 16) Engineers - Manufacturing, Validation and Production (page 18) Working in partnership with European Device Solutions Ltd, Procorre are representing businesses and products through registration for CE mark, complaint handling and deal with any incident reports which may arise in the future. 6
Sector Overview Medical Devices Medical devices have a significant importance to our lives as without them we would not be able to diagnose medical conditions, treat diseases or improve our quality of life. Medical devices can range from a one off usage, for example a syringe or bandage, to implants and larger imaging machines such as an MRI or X-ray machine. Devices fall into three classifications - Class I, Class II and Class III. The class classification is risk based due to the nature of the product, the associated risk to the patient and the regulatory levels required to get the device to market. 1. Class I - General Controls: example - bandages and stethoscopes 2. Class II - General Controls and Special Controls: example - pregnancy kits and X-ray machines 3. Class III - General Controls and Pre-market Approval: example - breast implants and pacemakers 7
Sector Overview In-Vitro Diagnostics In-Vitro Diagnostics (IVD) is an important segment in the global healthcare industry due to the rapid growth in the market place as a result of technological advancements, better diagnostic tools, improved treatment monitoring, and increased availability of overthe-counter tests. IVDs add significant value to treatment processes and medical diagnoses, enhancing the well-being of the general public. IVDs must comply with the new IVD Regulation (IVDR) a revised set of regulatory requirements to gain a CE Mark for any product. The aim of the directive is to ensure patient health and safety, by achieving performance levels set out by the manufacturer, for their products to comply with essential requirements. 1. Class A - Low risk products: example - clinical chemistry analyser 2. Class B - Slightly higher risk: example - pregnancy self-testing 3. Class C - Slightly higher risk again (with addition of pre-market submission of technical info to notified bodies): example - blood glucose self-testing 4. Class D - Higher risk products: example - HIV blood donor screening 8
Overview of ISO13485:2016 Changes to ISO13485:2016 have placed a greater emphasis on Quality Assurance and Regulatory Affairs. Over the next few years, ISO13485:2016 will allow manufacturers, accreditation or certification bodies and regulators time for transition to the new standard. 9
Overview of ISO13485:2016 A significant driver of the revision was the need for a global harmonised platform for quality systems and emphasising risk management throughout a quality system. This means any Medical Device (MD) or In-Vitro Diagnostic (IVD) that doesn t comply with the new ISO13485:2016 standards in the set timeframe will be refused access to key markets including the EU and US. The new standard requires 80 per cent of products that previously didn t require intervention from notified bodies as self-test or Class B, will now need to be reviewed based on revised classification. 10
Overview of ISO13485:2016 ISO13485:2016 will have huge implications for manufacturers and third party suppliers, who now have less than three years to upgrade their quality management systems (QMS) to ensure medical organisations can operate lawfully. The regulatory changes mean the industry is facing an international shortage of medical device contractors, who are qualified to support the sheer volume of organisations needing to upgrade or replace their products ahead of the fast-approaching deadlines. For example it is estimated that around 300,000 QA contractors alone will be required, though currently only about 36,000 have the relevant expertise. 11
Regulatory Affairs Regulatory Affairs (RA) specialists have a unique skillset with a combination of scientific, legal and corporate awareness. They are actively involved in every phase of the development of the medical device life cycle, including manufacturing and marketing of the device. Responsibilities include regulatory compliance, liaising with notified bodies, state, local regulatory agencies and advising companies on their regulatory duties. Procorre are looking to place RAs with the following levels of experience: Affairs Assistant Vice-President Officer / Executive / Associate Associate Director / Director Senior Officer / Senior Executive / Senior Associate Manager / Senior Manager Specialist Project Manager 12
Regulatory Affairs Our consultants have worked across the following specialist areas: UK Regulatory Affairs EU Regulatory Affairs International / Global Regulatory Affairs Emerging Markets Regulatory Affairs Regulatory Operations Chemistry, Manufacturing and Controls (CMC) Regulatory Artwork / Labelling The regulatory function in the healthcare sector is vital in making sure safe and effective healthcare products are available worldwide. We have RA professionals who can ensure regulatory compliance, prepare submissions for the necessary licensing, marketing and legal components, in order for products to be allowed entry into the market place. 13
Quality Assurance Quality issues rightly concern every stakeholder in the medical device industry, from manufacturers and regulators to suppliers, doctors and patients. The media attention surrounding quality control has increased over recent years and the punishments are severe when it comes to quality issues. We defined the optimum level of quality as the one that reliably meets or exceeds the expectations of customers and regulators while maximising competitive advantage and shareholder value. A company s quality performance can affect its business performance, which is why we offer the best in the field, offering the best practices. We understand that Quality Assurance (QA) is a diverse role which can often vary depending on what a company produce, the market place, regulatory authorities and the procedures put in place. QA professionals require a number of key skills ranging from auditing, handling customer complaints, generating reports, managing validation and leading investigations. Our QA experts are responsible for the development and manufacturing medical devices to ensure the process is performed in compliance with regulatory requirements. 14
Quality Assurance As our QA professionals influence working practices and improve standards of quality, we only place individuals of the highest calibre in a variety of key roles across different projects, processes and global locations. Procorre are working with QAs with the following levels of experience: Quality Administrators QA Manager QA Auditor QA Officer / Quality Officer Quality Specialists Head of Quality Qualified Person (QP) 15
Research & Development Medical device research & development (R&D) teams are constantly facing a number of business and regulatory challenges, resulting in longer product development cycles and escalating product costs. With an increase in demand for medical devices in particular from emerging markets, this has led to an acceleration of product adaptation for these markets - putting increased pressure with limited resources to cope with the demand. At Procorre we have an in-depth knowledge which enables us to understand and ensure that we only provide the highest calibre of R&D to all our clients. We cover a wide range of roles across the clinical, science, pharmaceutical, biotechnology industries as well as medical device and engineering sectors. 16
Research & Development Procorre Consultants have extensive specialist knowledge of the R&D market, this means we can provide the best talent and staff major projects around the world. Procorre are looking to place R&D specialists with the following key skills: Computational Chemistry Analytical Chemistry Formulation Chemistry Process Chemistry / Scale Up Organic / Medicinal Chemistry Molecular Biology Cellular Biology Pharmacology Structural Biology Genetics 17
Engineers Procorre understands the unique requirements companies within medical device development face when resourcing. Engineering roles in particular can be diverse, which is why we are able to identify, place and manage an entire workforce, to address a client s unique requirement and challenges in areas of skill and regulatory compliance. All our specialist engineers have an extensive knowledge of economics, mathematics and science. Their knowledge base ensures they are not only strong problem solvers but they have the abilities to concept, design and test theories in order to be developed to a large scale production. 18
Engineers Engineering skill sets can vary greatly but some of the key specialties we provide are: Facilities Engineer Controls Engineer Process Engineer Automation Engineer Chemical Engineer Electrical Engineer Bioprocess Engineer Software Engineer Production Engineer Product Technologist Quality Engineer Mechanical Engineer 19
Summary Your business will prosper by partnering with Procorre. Our advice and consultancy services allows us to manage the entire project life cycle providing: expert project services; trusted talent mangement; and efficient global mobility. Project Services By engaging our project services, Procorre will guide you through challenging periods of transition, identify opportunities, manage risks and design effective, competent organisational structures. Talent Management Using our talent management services ensures that you appoint proven, high calibre professionals to successfully complete your projects. Global Mobility Our global mobility services will help you expand into new markets and satisfy diverse legal and regulatory requirements. We also help consultants arrive in country, on time; eliminating any distractions from executing your projects to exemplary standards. 20
Contact Us Partnering with Procorre can boost your projects chances of running to cost, time and quality. Contact us to find out more about our comprehensive services or explore a bespoke package of services to meet your business distinct needs. Ireland: +353 151 34 777 UK: +44 203 43 204 80 Singapore: +65 3158 7777 21
LONDON GENEVA SINGAPORE DUBLIN Registered Address: Procorre, 33 Ubi Avenue 3, #08-61, Singapore 408868 T +65 3158 7777 F +65 3158 7778 22 PC00560_001