{"product_id":"ims-medical-device-manufacturing-iso-13485-iso-9001-iso-iec-17020-iso-31000","title":"IMS Medical Device Manufacturing (ISO 13485, ISO 9001, ISO\/IEC 17020, ISO 31000)","description":"\u003cp\u003eThis Integrated Management System equips medical-device manufacturers to design, produce, and place safe, compliant devices on regulated markets. It integrates ISO 13485, ISO 9001, ISO\/IEC 17020, and ISO 31000 into a single quality and risk framework aligned with global regulatory expectations. The documentation governs the full device lifecycle: design and development controls, risk management, purchasing and supplier control, production and process validation, sterilization and cleanliness where relevant, traceability, and post-market surveillance including complaints and vigilance. A master Quality Manual sets device-quality policy and regulatory responsibilities, supported by procedures for CAPA, nonconforming product, change control, UDI and labeling, and management review. Validated forms and records maintain the device master record and technical-file evidence auditors and notified bodies require, while checklists translate ISO 13485 clauses into daily manufacturing discipline. Training modules build and evidence workforce competence, and the ISO 31000 layer embeds structured risk management throughout. This kit is ideal for manufacturers pursuing ISO 13485 certification, CE marking or equivalent market access, or supplier approval by larger OEMs. Every document is fully editable to your device types, processes, and facilities, removing the burden of building a technical quality system from scratch. By harmonizing quality, inspection, and risk requirements, it strengthens product safety, streamlines audits, and accelerates certification and market entry. The outcome is a manufacturing operation that consistently produces conforming devices, satisfies regulators and notified bodies, and continuously improves — protecting patients and securing your access to demanding markets.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eIncluded:\u003c\/strong\u003e 65 ready-to-use, fully editable documents (manual, procedures, forms, records, checklists, guidance and training material).\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eLicense:\u003c\/strong\u003e single-organization license; delivered electronically as a ZIP archive.\u003c\/p\u003e","brand":"Apex Global Solutions AGS","offers":[{"title":"Default Title","offer_id":56517066719572,"sku":"AGS-09-014","price":2800.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1052\/4996\/4372\/files\/IMS-Medical-Device-Manufacturing-ISO-13485-ISO-9001-ISO-IEC-17020-ISO-31000.png?v=1784574573","url":"https:\/\/agskits.com\/products\/ims-medical-device-manufacturing-iso-13485-iso-9001-iso-iec-17020-iso-31000","provider":"apex global solutions","version":"1.0","type":"link"}