George Buchan Email & Phone Number

Prestwick

George leads his team to support UK, EC and Internationally based biomedical organisations to define, design, implement QA & RA controls to meet and maintain standards / regulations for long-term implantable; transient; short term; stand alone software devices; surgical tools, surgical accessories, active and active diagnostic and therapeutic devices; active implantable devices, IVD's and combination / Companion diagnostic devices including pharmaceutical and ancillary products. Utilising his extensive expertise, George provides support in both strategic direction / practical planning and hands-on implementation of the controls necessary for:-Device concept verification / prototyping, risk management, design validation, manufacture & clinical performance evaluation to reduce design to market lead time. -Selection and liaison with competent authorities, regulators, assessors, inspectors, registrars and Notified Bodies- Quality Management Systems to meet National and International Standards such as ISO 9001, ISO13485, CFR820, Japan MHLW Ordinance 169, BGMP, China and Mexico GMP requirements, and application of MDSAP.- PMS and PMCF planning, including data analysis & improvement, controlling change and maintaining QMS, Technical Documentation / Dossiers incl. DHF, MDR, Risk Management File,

Prestwick

"Management Systems Development and Implementation."George worked with various companies and sectors to design & implement of QMS to achieve BS EN IS0 9000: the first Employment Recruitment Agency to be registered in Scotland; the first Museum Training Agency in the UK, the first Thermal Printer Manufacturer; the first Electronic Console Manufacturer; the first Bovine Semen Supplier; the first Bovine Semen Shop; the first Taxi-Cab Company to be registered in the world, all achieving success at first assessment. Related sectors covered: Clean Rooms, Laundries, and Medical Device Manufacturers, Medicine manufacturing control and distribution. Through process analysis and the compilation, documentation, and implementation of business-focused procedures, both operational management and quality of products/services have been enhanced in these organisations.

Uk

Strategic Management, TQM and Customer Care Standards Development."Conducted strategic reviews with Boards of Directors and government agencies to implement effective business plans for Companies in the service, professional services, and manufacturing sectors. These projects have involved in some cases Benchmarking, Organisational and Customer surveys to identify the perceptions of service and product standards. Developed strategies, including HR training and development, to aid the implementation of effective, key organisational performance measures which directly relate to customer expectations and bottom line. To enhance the problem solving capability of organisations, programmes have been developed and staff / facilitators trained in the practical application of tools and techniques, (SPC, Team Leadership / dynamics, Problem Solving, Benchmarking, Cost of Quality) which have facilitated, harnessed and improved operational capabilities."Quality, Safety, Environment, Business Continuity Planning and Risk Management"Developed and conducted organisational surveys to establish the current issues and perceptions relating to risk, safety and quality in a nuclear based company. From the survey results, recommendations made regarding organisational structure, staff involvement, training and reporting systems, to facilitate change in perceptions and to enhance customer focus, safety and efficiency of operations.

Mba

Applied Chemistry, Dyes & Pigments