Medical Devices

Audit

NSF-DBA Medical Device Quality and Regulatory Audit Solutions

Medical Device organisations are seen as one of the most audited industries today. From customer audits, regulatory agency audits to internal audits the field of auditing and methods of auditing are complex, stressful and more importantly difficult to manage.

As a division of NSF Health Sciences, NSF-DBA has assembled an “A-Team” of medical device auditors and created a series of offerings to help you to prepare, execute, follow-up and enhance your auditing capability. These tools range from the general audits against common regulatory frameworks such as the US FDA Quality systems inspection techniques to helping you to benchmark your regulatory compliance throughout global locations with varying product lines, technologies and creating real risk profiles based upon sound fundamental principles.

Consultancy

The NSF-DBA Medical Devices division offers a range of consultancy services to assist clients…

at whatever their market entry level, type of service provider and organisational capabilities, realise and meet the changing needs of the Global Medical Device market.

From experience NSF-DBA understands that their client base and clients needs will greatly differ commercial and geographically so a group of NSF-DBA associates has been developed to provide the knowledge, skills and experience to provide a ‘menu’ of services to assist a client identify market needs and regulatory requirements and to support a client’s idea through to a successful strategic business conclusion.

The Service Menu

The NSF-DBA Medical Devices division’s comprehensive ‘menu’ of consultancy services is offered to meet the different needs of a clients, from the project management of a new device from design concept to market launch, launching an existing product into a new market, remedial action for a legacy product to meet changing business and regulatory essential requirements, through to changes in the contracted supply change manufacture of a new or legacy product.

To ensure that a client selects correctly from the ‘menu’ of services NSF-DBA Medical Devices division have created a core team whose commercial, regulatory and strategic ability is, in the interest of the client, focused initially on an audit of the following:

• The Client’s ideas, concepts or project type
• The Client’s expectations
• The Client’s organisational capabilities
• The Client’s time schedule
• The Client’s financial expectations
• The Client’s business needs

Based upon the audit findings the core team will present a bespoke project plan, project team and costs to meet specific requirements, enabling the client to contract with NSF-DBA the right support to innovative new product, take strategic decisions, control development budgets and grow the business through best practices. This process is shown

The Consultancy Team

The NSF-DBA Medical Devices division’s consultancy team is a group of associates who represent a combination of specialist and specific skills, built upon a comprehensive knowledge of the medical devices industry and collectively more than 25 years experience. Collectively the associates cover the following medical device related disciplines to ensure a full “menu” of services to enable a client’s innovative product and subsequent business growth through best practices.

• Business and Commercial Needs
• Global Market Needs
• Clinical Needs
• Development Needs
• Global Regulatory Requirements
• Quality Management System Needs and Capabilities
• Human Resources
• Manufacturing and Process Needs
• Market, Device and Manufacture’s Related Legal Needs

While providing the support and services above, all of the NSF-DBA associates irrespective of their individual input, are very aware of the many other related demands placed upon their decision making and the need for an organisation to meet an increasingly commercially sensitive market and therefore the associates ensure that in their work must be performed in parallel with other associates to support overall the commercial and business needs of the client.

For more information, please download our full consultancy service brochure or contact us on +44(0) 1143 600868 or emailing devices@nsf-dba.com

Diploma

Medical Device Diploma: Learning through doing with experts at your side

NSF-DBA launch a ground breaking work based Diploma for the medical device industry. After 18 months of development and a major survey of medical device quality and regulatory learning needs we have formulated a body of knowledge that has identified all of the major aspects of becoming an effective professional within Medical Device Organisations.

When developing the Diploma learning philosophy we understood the importance of flexibility for our students; firstly in the way that they approach study and secondly in the way they can demonstrate achievement of the fundamental body of knowledge. With this in mind, the modular approach, work based correspondence methods supported by expert tutors and the accreditation of prior learning make this Diploma the most unique learning product within the field of quality assurance and regulatory affairs. The Diploma itself offers eight core modules to provide the modern medical device professional with the knowledge, tools and techniques needed to manage the many aspects of worldwide medical device quality management and regulatory affairs.

The Diploma Core Modules are:

• Module 1 Medical Device Regulatory Frameworks
• Module 2 Medical Device Risk Management Design Development and Product Validation
• Module 3 Medical Device Clinical Evaluation
• Module 4 Medical Device Conformity Assessment – Preparing and Managing Technical Documentation
• Module 5 Medical Device Conformity Assessment – Implementing and Managing Quality Management System Processes
• Module 6 Medical Device Post Market Surveillance and Vigilance
• Module 7 Working with Competent Authorities, Notified Bodies and other Regulatory Stakeholders
• Module 8 Management and Behavioural Skills in Quality Assurance and Regulatory Affairs

The NSF-DBA Diploma has been developed by experts from the field of Medical devices and ensures an approach to learning which can be transferred directly back to the workplace. A major aspect of the Diploma is the end of module Written Assignments and the Work Based Project. Our Experts will mentor each individual and ensure the content of the assignments and work based project are based on activities that can be completed or evaluated within the workplace.

We believe whole-heartedly in this ground-breaking approach and are proud to claim that the Diploma allows our students to ‘learn through doing ‘ with our ‘experts at your side’. Further information about our assignments and work based project are below.

NSF-DBA Diploma Work Based Project

• Background – The work based project is a unique feature of the NSF-DBA Diploma where you are challenged to apply your learning in practice within your work.

• Process – Your work based project will depend upon what you have done in the past as well as the challenges you face currently within your organisation. The work based project is usually required to be sponsored by a senior manager within your organisation, although it is accepted that this may not be the case for all students.

• Benefits
  • Successful completion of a work based project will allow you to practically apply the knowledge gained in the Diploma to a real scenario within the workplace
  • This industry leading learning approach ensures excellent professional development through maximising your learning experience
  • You will gain access to a medical device expert within the subject matter area
  • Work based project marking is in accordance with international education quality assurance standards to ensure your competence
  • You will receive a comprehensive consulting report from an NSF-DBA expert on your work based project which you will be able to utilise within your organisation

NSF-DBA Diploma Written Assignments Medical Device Diploma

• Background – After each module you will be required to complete a written assignment for all eight modules, which is a key part of the Diploma. The assignments will allow you to practically apply the knowledge gained from your learning into your work.

• Process – At the end of each module you will be provided with a range of questions where you can select the title of the assignment to match your learning needs or work interests. The NSF-DBA subject matter expert will give you full support and give you comprehensive feedback on each assignment in the form of a detailed consulting report which you can utilise within your organisation.

• Benefits
  • Successful completion of assignments allows you to practically apply the knowledge in the Diploma gained to a real scenario within the workplace
  • This industry leading learning approach ensures excellent professional development through maximising your learning experience
  • You will gain access to a medical device expert within the subject matter area
  • Written assignment marking is in accordance with international quality assurance standards to ensure your competence
  • You will receive a detailed consulting report on each written assignment from an NSF-DBA expert which you can utilise within your organisation

Training

Our approach to learning is to ‘learn though doing with experts at your side’.

Our training solutions are highly interactive and based on ‘real’ problems and scenarios within the Medical Devices Industry. Many training providers focus on what the devices Industry requires you to do, we focus on how to run your business at all stages of the product development lifecycle.

Our capability allows us to help you at all stages of the product lifecycle, through our training we can help you:

• Plan the regulatory pathway to a specific market
• Review your Design, Risk Management and Product Validation Strategies
• Place a device into Europe, US, Canada or Asia
• With the latest world-wide regulatory interpretations and actions that are slowing your ability to release your product
• Review your processes and provide critical benchmarking against competitors or industry leaders
• Design, Implement and review technical processes including biological safety, GMP, Process control and manufacturing validations

Our associates are the very best in the business (see our people page), many heading technical standards committees and all are recognised as leading experts within the medical device industry. We have unique project management and communication tools that bring these associates together on consultancy engagements, audits or training delivery. We have the capability of building any training course for your requirements.

Most of our training is delivered at our specialist training suite based at the heart of engineering and manufacturing industry in the centre of the UK.

We also have helped a number of major Medical Device companies by delivering training ‘in house’ and helped key Customers develop an suite of medical device courses using our ‘Academy’ approach to learning.

After 18 months of development and a major survey of medical device quality and regulatory learning needs we have formulated a unique Body of Knowledge that has identified all of the major aspects of becoming an effective professional within medical device organisations. We have used this unique body of knowledge to develop training solutions for a series of courses within medical devices for the following areas:

• Design
• Regulatory
• Process Validation
• Quality Assurance
• Auditing
• Clinical

Full series brochures for the above areas are available on request by contacting us on +44 (0) 1143 600868 or emailing devices@nsf-dba.com