Services

 

Services

From unmet needs to manufacturing control and scale up, we can help deliver your product quicker and with less risk.

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How can we help?

Design

 

 

Device design and analysis of novel and custom injection or respiritory products for pharmaceutical drug delivery. Unmet needs analysis or interpretation, design inputs - User Requirement Specification creation and review, Design Input Requirement or Technical Product Specification. 3D and 2D design outputs. Liason or management of Design and/or Contract Manufacturing Organisation/Partner or design partners. Challenge of expert or second opinion. Design verification planning and management of validation activites with IFU design.

Customisation and deep dive analysis of existing or off-te-shelf products. Trouble shooting and pragmatic solutions are our speciality. With our knowledge there is no long learning curve.

Quality Systems

 

 

Identification of applicable standards, review of existing systems for compliance with design controls acccording to 21CFR820, EU Medical Device Directive, ISO13485 and ISO14971.

Standard Operating Procedures and guidance documents, Design verification and biocompatibility reporting. Identification of key or critical quality attributes for quality and manufacturing control. Full integration with risk management.

Risk Management

 

 

Creation of and maintenance of risk management systems in full compliance with ISO14971 and EU and US regulatory requirements fully linked to design inputs and design outputs, quantified or based upon engineering analysis to evalaute risk of a hazardous situation and resultant harm from cause. Simple and effective implementation to leverage and quantify existing knowledge and identify gaps. Preliminary Hazard Analysis through to Design, Process and Apllication/User risk assessment.

Manufacturing and Control

 

 

Design for Manufacturing and Assembly analysis. Manufacturing method design and planning. Contract Manufacturing Organisation/Partner assessment and selection. Pilot or rapid tooling and manufacturing for clinical supply. Transition and scale up from clinical to commercial supply.Quality by Design - integration and alignment of manufacturing controls to quality attributes and associated risk/severity.