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Technical Documentation
Whether targeting the US, European or Canadian market, technical documentation is an important deliverable for MedTech and Pharma companies during the submissions process, as well as for audits.
Making the technical documentation specific to a particular product as well as putting the required processes in place for maintaining the technical documentation is a challenge for many companies in the life sciences industry.
At Technolution, we are often called in to help an organization create the overall structure of the technical documentation, and furthermore to establish the processes for keeping the documentation up-to-date, when product changes occur.
Design control is a closely related area, since it feeds a lot of documentation input on to the technical documentation. Design control is another of the in-house skills at Technolution, alongside areas like mechanical engineering and quality management, which work closely with our regulatory affairs specialists. This cross-sectioning of medical device development skills ultimately benefits the quality of the services we offer our clients.