Whether you're looking for EU or US certification (ISO 13485, FDA CFR for example) you will need a documentation pack of processes, forms and test results to demonstrate compliance with the standards. We have created SUCCESS PACKS of templates of all the required documents that can be simply customised for you - so you don't have to start from scratch. Our packs have passed many regulatory audits around the world in different industries. The packs can contain up to 100 documents depending on the standard you are going for. We offer three levels of support for you which can be seen in the section below. Please get it touch for a free consultation and initial advise on your optimal route to regulatory and quality success.
In the lite option we provide you a bundle of pre-approved documents, forms and reports (with completion instructions) Your team complete the highlighted sections to customise to your business and you provide your own training (or we can help with this). We have highlighted the sections in each document you need to customise to you and have included instructions.
The custom option provides the same as success pack 1 but we will provide an experienced quality and regulatory expert to work with your team to complete them, provide training and be available to answer any technical questions. We will walk your team document-by-document through the process and provide detailed training.
Our most popular option. In the managed certification option you get the same as the custom option 2 BUT our consultants will host and manage the certification audits for your certification (there will be at least two independent audits to gain certification) maybe including you key suppliers being audited too. We can de-stress this very difficult process for you.
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