Walt Medical Editions! ™ The COST of Non-Compliance (failure to execute to Requirements) grows EXPONENTIALLY: during product development — from concept thru design, prototyping, verification, validation, pre-clinical/clinical, market/post-market. by Product complexity — including Performance, Risk Classification including human-body contact, requirements for Sterilization, etc. by extent of use of Suppliers — whether “Outsourced Design” and/or “Virtual Manufacturing” Suppliers are used, etc. Editions! provides all the SOPs for an Enterprise to successfully Operate to the Regulations, including Product Design & Development (D&D) Templates of substantial value, which help to minimize Management and Technical resource time - and thereby Investors’ Risk and Total Cost! Editions! is a proven-effective, ideal suite for Startups or Small Companies wishing to implement an essential Quality Management System for the first time, launch a critical new Product, meet new Regulations and/or deliver a new level of Quality. We assist Clients in reaching the next level of Product Development, Quality and Compliance! Product Highlights! — Registration and Purchasing Company agreement to Limited Warranty & SW License Agreement required. All sales final (Non-Refundable). “Thanks for the excellent orientation yesterday. This system will really help us accelerate our plans! I’ll let you know if we have any... basic questions as I plow through the multitude of documents!” VP of Business Development, Startup Catheter Company, SoCal. Family of Products SERIES VOLUMES DESCRIPTION : : Request an Appointment to share your need and learn more! Client Prospects CLICK to get Started! OR CLICK to See our Projects! Sales Affiliates CLICK to Contact Us! · S1 · V1, 2, 3, 4 · QMS & Product D&D Templates — for US Startup & Small Co. Medical Device Manufacturers · S2 · V1, 2, 3 · QMS & Product D&D Templates — for US Startup & Small Co. OTC Pharma Manufacturers · S3 · V1, 2, 3 · QMS & Product D&D Templates — for US Startup & Small Co. Cosmetics Manufacturers · S4 · V1, 2, 3 · QMS & Product D&D Templates — for US Startup & Small Co. Cosmetics & OTC Pharmaceuticals Manufacturers · S5 · V1, 2, 3, 4 · Integrated QMS & Product D&D Templates — for US Startup & Small Co. Manufacturers (3 industries above) · VOLUME 1 · Full Quality Management System for Low-Medium Risk Products · (editable Manual in MS Word & Access®, SOPs (Level I, II, III), US/EU/CAN compliant, PC/Network (premises, multi-site or Cloud-based)) · VOLUME 2 · TEMPLATES for Low-Medium Risk Product Engineering & Management Design & Development · (for Prototype Development phases, thru ISO ST1 Audit) · VOLUME 3 · TEMPLATES for Formal Verification & Validation, Build, Testing · (for V&V Phases, thru ISO Certification, incl. Class I Self-Cert Registration/Marketing Notice) · VOLUME 4 · TEMPLATES for STERILE Product and those requiring Clinical Study/Evaluation · (incl. for (US) Class II (510(k), De Novo); (EU) Class Is/IIa/IIb and CE Mark/Marketing) · VOLUME 5 · TEMPLATES for High-Risk Products Engineering & Management D&D for Class (US) III, (EU) III, (CAN) IV & heavy Onsite Manufacturing · (for Formal Product Build, V&V, Onsite Production, for High-Risk Devices, thru ISO 13485 Cert) · Supports “essential Internal” Product D&D activities! · Management, Engineering, Purchasing, Quality, Regulatory, Manufacturing · Supports “key Outsourcing” of “Virtual Manufacturers”! · Sterilization services, Contract Engineering & Manufacturing (CE/CM) · Supports multiple Product Types and Classifications! · Mechanical, Electro-Mechanical & SW Systems — Class I/Is, II/IIa/IIb (US/EU) · Supports multiple Legal Domains! · US 21 CFR 820 (QSR), EU MDD 93/42/EEC, Health Canada. · Proven (Resulted in) Certification(s)! · Certified compliant QMS, by an accredited Registrar to EN ISO 13485:2016, with extensions to comply with CMDCAS (Health Canada), including by definition compliance to EN ISO 14971:2012 for Risk Management — to Class