Services
DESIGN & DEVELOPMENT
The whole of the product lifecycle needs to be considered at the outset of the product design. The fundamentals of Design for Manufacturability (DFM), Test and Service ultimately reduces the total product cost, time to market and field service to everyone in the product lifecycle and enhances job and customer satisfaction.We can assist with any or all phases of product D&D from concept and planning to transfer to production including; risk analysis (DFMEA), the development of specifications, design reviews, verification / validation protocols, reports and the creation of a Design History File.
MANUFACTURING ENGINEERING
The aim of manufacturing engineering is to turn raw materials and components into a new or updated product in the most economic, efficient and effective way possible. The increasing demand to make the ‘best’ possible decisions in product design and manufacturing process at decreasing costs and a faster pace requires knowledge of methods in design and production optimisation. The challenge is to achieve this goal whilst still meeting the strict medical device, defence and aerospace quality, safety and reliability standards. We can assist with 'state of the art' technology investigations, development of manufacturing processes, process risk analysis (PFMEA), factory layout, equipment qualification (IQ/OQ/PQ) and creation of Design Master Files.
QUALITY ASSURANCE
Medical devices, aerospace or defence industry products are required to be designed, manufactured, marketed and supported in accordance with industry and regulatory standards. To achieve this a Quality Management System (QMS) is needed to be established, certified and maintained to an international standard such as ISO 13485 and/or the global Medical Device Single Audit Program (MDSAP) for medical devices, or AS9100 (for aerospace / defence). We can assist with both the establishment and certification process of an applicable QMS. This Includes assisting with the creation or improvement of a Quality Plan, the required Quality Manual, Standard Operating Procedures, supplier audit and selection of suppliers, internal audits, risk assessments, post market surveillance, corrective and preventive actions.
REGULATORY AFFAIRS
Regulatory Affairs (RA) is about knowledge of the laws and regulations relating to industry and products and using the knowledge to find the best process to meet those requirements and enabling structured interaction with the regulatory authorities. We can assist with regulatory strategy, preparation, collation and submission of registration dossiers with appropriate authorities and being the principle contact for interaction.