Services

UK Distribution

  • Speciality Areas of Spine, Extremity & Shoulder Surgery
  • Generate UK Sales with continued growth
  • Develop Product and Brand recognition across the UK
  • Establish leading KOL's and reference centres within the UK
  • Assist in Clinical Data Collection
  • Assist in essential post market surveillance feedback

Third Party Logistics (3PL)

  • Subcontract warehousing, inventory management and shipping services
  • Flexible service agreements to meet each manufacturers requirements
  • Full lot traceability of all items through a dedicated ERP computer system
  • Management of loaner/hire sets used for specific surgical cases
  • Management of consignment stock in hospitals and or overseas distributors
  • Reduce lead times in getting product to market
  • Customer services function with dedicated invoicing in the manufacturers name where required
  • Management of logistics in accordance with each manufacturers quality management system, if required
  • Accounting and book keeping services available

Expert Sales and Distribution

  • Identify and assess each potential territory distributor for their suitability to represent each current and future technology
  • Establish a product focused worldwide distribution network
  • Manage contract negotiation, sales training and surgeon training
  • Manage business development strategies and sales growth with each distributor
  • Perform territory visits with each distributors sales representatives to assist in the business growth and sales development

Marketing

  • Develop marketing tools to support the sales and marketing activities
  • Integrate the tools into the training programs to ensure maximum effectiveness
  • Continual improvement and review of these and new marketing tools

Training Programs

  • Develop a fully modular training program for internal personnel, sales personnel and end users to cover the specifics of each device at every level
  • Deliver training programs and presentations to each of the above groups focusing on their specific requirements
  • Monitor training program effectiveness and expand the programs as the clinical data and evidence develops
  • Produce training programs that demonstrate how to sell against the competitors

CE Marking

  • Produce a Quality Management System (QMS) to enable the manufacturer to satisfy CE Marking regulations
  • Build or advise on the structure, implementation and maintenance of a QMS to satisfy CE Mark Criteria & Regulations
  • Advise on the production or produce the Technical Files and all necessary documentation to achieve initial Certification and the maintenance and renewal of these
  • Manage the documentation and process to achieve ISO13485 Accreditation
  • Ongoing management of the QMS
  • Notified Body liaison to maintain Certification & Accreditation
  • Audit management and/or preparation

FDA 510(k) Clearance

  • Guide companies with CE Marked product to implement an appropriate route through the FDA 510(k) approval process
  • Build or advise on the structure, implementation and maintenance of a Quality Management System (QMS) to satisfy FDA 510(k) Clearance Criteria & Regulations
  • Prepare relevant documentation for filing with the FDA
  • Submit relevant documentation to the FDA
  • Liaise with the FDA to provide relevant information whilst filing is reviewed
  • Post approval liaison and ongoing management of Registration
  • Ongoing management of the QMS
  • FDA Audit management and/or preparation
  • Post Audit action implementation

Product Development

  • Assist in the assessment of new product development ideas
  • Provide the liaison point between the development surgeons and engineers to ensure clarity
  • Establish, manage and/or be involved with surgeon advisory boards (SAB's)
  • Develop marketing plans for each specific technology
  • Develop routes to market