At ABC, we believe that integration of all teams and disciplines is vital for the long-term success of any organisation, particularly in the life-science sector, which relies on solid documentation. A robust Quality Assurance approach can provide the tools and structure you need to succeed.
Risk Management is one of the key requirements of this industry and, if used correctly, it can provided a firm basis for organisational decision-making. This, in turn, will allow a well documented process to become a key factor in all business decisions. Implementation of a well structured process for risk management, starting from early product development through to manufacturing, is a vital step to help avoid costly mistakes which can blight a project.
Following ISO14971, and using techniques such as pFMECA , dFMECA and fault tree analysis, we can help develop a risk management strategy for your business.
Product and Process Validation
Well documented validations of your product and manufacturing process capabilities are some of the most important and useful documents you will generate. If used properly, in conjunction with risk management techniques, these documents are the evidence that your product works as you say it does - and shows your process is capable of consistently delivering product to specification. Validations range from special processes such as sterilisation and decontamination, through to CNC milling and welding, as well as validation of product performance against recognised standards.
We can develop protocols, execute these protocols and generate detailed reports that support these requirements.
Software Validation (Electromedical)
In a world which is increasingly driven by “Apps” and other software products such as personal fitness monitoring systems, regulators have often not enforced the highest standards of compliance for software in the healthcare arena. This is all changing with the news that specific emphasis on the importance of software is taking high priority in the draft text of new European regulations, as well as in FDA guidance documents and new drafts of ISO13485. In software, probably more than any other development area, it is vital that a disciplined process is followed from very early on in the development process. We can bring specific experience in the development of software and electro medical devices to your company, which can save you significant issues in the future.
Measurement and Testing
Does your product meet its stated specification (print)? With recent changes to enforcement in Europe prior to the implementation of new regulations, Notified Bodies are conducting unannounced audits of manufacturers. One of the features of these visits is the testing of the product to demonstrate that it meets specification.
Using our extensive knowledge of suppliers in Europe, we will be happy to arrange Third Party testing of your products. We do this on a cost basis and only charge for our time in organising testing services.
Manufacturing Techniques Building
A robust process for the delivery of your product could be the key to avoiding costly damage to your reputation and increased manufacturing costs. We can use our extensive risk management and process validation knowledge as key tools to develop efficient manufacturing systems that work consistently. Techniques such as Poke Oke, Gauge R & R, automated measurement systems development and process flow analysis are all used to minimise mistakes and maximise reliable manufacturing.