MCS Biomed

Dr George D. Boukouris, BA'91
The AMP Technology Centre, Advanecd Manufacturing Park, Brunel Way, Rotherham, S60 5WG, UK
george@mcsbiomed.com

MARKETING COMMUNICATIONS  Product launch services* o Brand development and identity including logos and halo images o Defined key messages, USP creation, validation and development o Brand guidelines o Campaign planning o All forms of media from detail aids, corporate brochures and case writing o Trade show stand graphics, exhibition stand design and build o Production of Congress/Conference media o Design and production of clean, modern printed literature o Extensive ‘re-versioning’ services – Language and format variants o Cost-effective updating of existing media to reflect product changes o Web design and media integration services o Our clients to utilise their media intelligently for different applications: from Websites, dedicated tablet / i-Pad media to various forms of print media, specific meetings and presentations  Fully rendered HD media including 3D o Corporate videos including a proven portfolio in clinical and non-clinical environments o Special Effects and Concept photography for both trade show and editorial use-- generating images that convey clear messages – especially for products for which there is no specific hardware to shoot – is often useful to clients.  Market research, and therapy development research and planning MEDICAL DEVICE AND PHARMACEUTICAL QUALITY ASSURANCE AND REGULATORY AFFAIRS AND OPERATIONS MANAGEMENT SERVICES  The demands to meet clinical efficiency and health economics is drastically changing the backdrop to the medical devices industry, creating “Pain Points” for all Stakeholders. Organisations must demonstrate their compliance to meet these demands while also meeting the increasing pressure to be competitive, achieve their business needs and grow within the changing healthcare market.  Understanding customer’s contractual and business requirements.  Understanding International QMS and Regulatory requirements o Experience in the implementation, control and maintenance of ISO 9001/2001 & ISO 13485 1996 based quality systems o Ability to manage and motivate staff at all levels within a multi-disciplined business o Able to implement and manage change in a timely, organised and cost effective manner, while balancing the immediate practical needs of a competitive and changing operation against long term business goals • Quality and Regulatory Audit Solutions o Regulatory Readiness Assessments (US / EU / UK / JAPAN / CANADA and World-wide markets) o Pre-Audit inspections (ISO13485:2003 : QSIT and CFR21 Part 820: CMDCAS and GD210 : JPAL and Ordinance 169) o Benchmarking and audit reporting tools o Audit strategy o Internal audits and supplier audits o Best practice systems health check o Technical file and design documentation audits o Supply chain audits, audit resource o Project, process and product audits and re-structuring of operations o Consulting, training and coaching o Competency audits o Technology audits o Full audit solution management