PROTEC Industries |
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International Packaging Consultants Protec is an international packaging consulting firm
specializing in the consumer and industrial sectors and active in forensics, regulatory
compliance, technical and business development. |
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Medical Device and Pharmaceutical Projects
Protec has designed and developed Class I and Class III medical devices. The firm has provided concept drawings to clients for novel drug delivery mechanisms. The company has extensive experience and can provide consulting services for a complete project in transdermal drug delivery systems from concept through full scale manufacturing. We can evaluate product designs, materials, methodologies, production processes and quality control protocols. Protec can provide international marketing assistance through its contacts throughout the developed and developing world.
Artery cath drill - Protec assisted in the development of a flexible artery cath device to clear blockages by drilling the channel to dislodge any foreign matter. We prepared specifications, diagrams, and recommended auxiliary materials for its use. Investigated issues included regulatory guidelines, procedure training and presentation in a sterile environment.
Diagnostic devices - Involved in the design, product development, process development and engineering of single piece diagnostic devices to be used in the detection of diseases and other medical conditions. Project work had Protec detailing the project administration, research and development activities, regulatory issues, operations including material sourcing, scheduling and shop floor control, pilot and full scale manufacturing commissioning and facility preparation for firms engaging in this market.
Skin contact adhesives - US based client had us source raw materials and compound and develop pressure sensitive adhesives for skin contact for use on medical devices. Conceptualized, created and administered research and development program, coating machinery design and development and start-up converting activities for an international customer. The firm provided routine documentation for the manufacturing operation.
Medical and electronic parts converting - Local established converting firm made Protec Industries their in-house research and development department. Duties included the technical administration and monitoring of six product lines, their improvements and cost reductions. Protec performed trouble shooting, product and process design, technical services and interfaced with vendors and customers on a daily basis concerning quality control of batched product.
Plastic converting of medical devices and their parts - The firm worked on design, engineering, product development, manufacturing processes, specifications and quality control methodologies for a class III device. Responsibilities included reviewing FDA guidelines, interpretation of the regulations, applicability of the device in clinical studies and modifications, materials and processing selection and pilot scale-up to manufacturing. Reports and project planning and management were maintained and documented weekly for the client and end use customer. We created the necessary specifications, engineering drawings and supporting documents for the customers PMA approval submission.
