{"product_id":"iso-13485-starter-kit-expert-check","title":"ISO 13485 Starter Kit + Expert Check (Kit, Onboarding Call and Document Review)","description":"\u003cp\u003eThe ISO 13485 Starter Kit, a 60-minute onboarding call and a fixed-scope review of your five highest-risk documents, in one order. Bought separately these cost $747. This package is $599.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWho it is for:\u003c\/strong\u003e a small medical device company, importer or distributor building its first ISO 13485:2016 system, where a full-time consultant is out of budget but you still want a senior quality engineer to check your work before the certification body sees it.\u003c\/p\u003e\n\u003ch2\u003eWhat you get\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003ca href=\"\/products\/iso-13485-starter-kit\"\u003eISO 13485 Starter Kit\u003c\/a\u003e ($249): the six kits most organisations need first. Quality manual and management review, document control and records, CAPA and nonconformance, internal audit, training and competence with eight ready modules, and the 71-area gap assessment workbook with its dashboard. Instant download, editable Microsoft Office files, no macros.\u003c\/li\u003e\n\u003cli\u003e\n\u003ca href=\"\/products\/kit-onboarding-call\"\u003e60-minute onboarding call\u003c\/a\u003e ($149): a remote working session to map the kit to your products, sites and regulatory pathway, agree what to customise and set a realistic timeline to certification. Booked within 90 days of purchase; you receive written next steps afterwards.\u003c\/li\u003e\n\u003cli\u003e\n\u003ca href=\"\/products\/document-review\"\u003eFixed-scope document review\u003c\/a\u003e ($349): send up to five adapted documents (for example your quality manual, CAPA procedure, document control SOP, internal audit checklist and training matrix). You get a written review against ISO 13485:2016 with clause references and the exact changes to make, within five business days of receiving all files, plus one re-review within 30 days.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eHow it works\u003c\/h2\u003e\n\u003col\u003e\n\u003cli\u003eDownload the Starter Kit immediately after checkout and read the Start Here guide.\u003c\/li\u003e\n\u003cli\u003eBook the onboarding call from the link in your order email; use it before you start customising, or once you have questions.\u003c\/li\u003e\n\u003cli\u003eWhen five documents are ready, email them for review. One round of written feedback and one re-review are included; a second call to walk through the findings can be added at the advisory rate.\u003c\/li\u003e\n\u003c\/ol\u003e\n\u003ch2\u003eWhy a kit plus a review, not a consultant\u003c\/h2\u003e\n\u003cp\u003eMost small device companies do not need someone to write their system for them. They need a structure that is already cross-referenced, and an experienced second pair of eyes at the two points where audits are lost: the first customisation decisions, and the finished documents. That is what this package covers, for less than a day of typical consulting fees.\u003c\/p\u003e\n\u003ch2\u003eGood to know\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e30-day money-back guarantee on the kit. The call is refundable until 24 hours before the booked time; the review is refundable until documents are sent.\u003c\/li\u003e\n\u003cli\u003eLicensed for one organisation, including its sites.\u003c\/li\u003e\n\u003cli\u003eTemplates do not reproduce ISO standards. You need your own licensed copy of ISO 13485:2016.\u003c\/li\u003e\n\u003cli\u003eAlready own the Starter Kit? Email us with your order number for a credit against this package.\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":68609563656386,"sku":"ICC-13485-STARTER-EXPERT","price":599.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-starter-kit-expert-check","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}