Reliable and cost-effective manufacturing gains consideration by a manufacturer in developing a complex life saving product. In simple terms, error prof transition of design specifications into a commercial product is must. This require engineers and production workforce to collaborate on each production deliverable through constant elimination of inherent process risks in each phase. Our consultants with expertise in manufacturing processes offer all round support in all manufacturing aspects.
Our services are not only limited to those categories:Bringing Design Concepts into reality involve series of brainstorming, inherent risk considerations, Verification and Validation activities proving functionality of product ensuring safety, and finally production workforce involving into processing steps to achieve the final product. In addition, careful review on performance of competitive and predicate products is equally important to constantly strive to enhance performance of New Products and Existing products in the market.
Our consultants offer clients hands on help in:Regulators and standard requirements expect legal manufactures to establish supplier controls at minimum to minimize the risk associated with supplier purchased components.
Our consultants provide clients their expert support in:New Product Development Projects involve a lot of clinical trials. Engineers and Scientists explore the factors such as user expectations, Convenience of product usage, possible risks of misinterpretations before the product moves into actual Development Stages.
We offer clients our expert support in:Validation of a product or a process ensures meeting the user needs through building right product or a correct process. Regulatory bodies require manufactures to constantly monitor and reports device failures. Lack of process and usability validations results in unsafe design outputs. Our consultants provide clients their expert support in implementing robust validations methods.
Lack of traceability to product deliverables, specifications and verification linkages result in poor data management requising further actions of fixing the noncompliance to requirements and standards. ISO standards require legal manufacturers to manage the product historical data effectively with transparency to user on the product performance. This includes understanding and implementation of new concepts of risk benefit approach evolved due to recent changes in EU regulations.
Our team help clients in special projects such as remediation activities in areas of: