Contact Us
- sales@fdaiso.com
We respond to most inquiries within 24 hours
Shop with Confidence
- Download your packages immediately after paying with your credit card or Paypal account.
- Your information is protected at all times by industry-standard SSL encryption.
Our FDA and ISO team designs and develops comprehensive, affordable, and ready-to-implement systems to comply with ISO standards and FDA, European Union, and Health Canada regulations.
We provide customized Quality Manuals, Procedures, and Forms. Select from our list of compliance solutions for ISO 9001, ISO 13485, CE Marking, CMDR, FDA – QSR, ISO 14971, standards and regulations. Then simply add your Company Name and modify the Procedures and corresponding Forms in accordance with your company practices. Your company can have ISO 9001, ISO 13485, ISO 14971, CE Marking, CMDR, FDA – QSR compliant quality systems in less than a day. Simple choose the compliance solution that best matches your business needs, or use our comparison chart to help you decide.
All products meet ISO 9001:2008 Standard!!!
FDA QSR System™ is specifically designed to meet FDA QSR regulations 21 CFR Part 820. Required by FDA for medical device manufacturing and servicing. Also meets FDA's 21 CFR Part 7 (Recalls), 21 CFR Part 803 (Medical Device Reporting), 21 CFR Part 806 (Corrections and Removals) requirements for medical devices...
- FDA QSR System™ - Quality Manual. Level 1 or "roadmap" to your company's QMS.
- FDA QSR System™ - 28 Procedures. Level 2 of your company's QMS.
- FDA QSR System™ - 19 Forms. Level 4 of your company's QMS.
Free samples of FDA QSR System™: Quality Manual | Management Review Procedure | Guide Book
Our systems are designed for Quality Technicians, Quality and Regulatory Professionals, Supervisors, Managers, and Executive Management with all levels of computer expertise. Increase your company’s productivity, effectiveness, efficiencies, and simultaneously meet FDA, European Union, and Health Canada regulations. Our simple, effective documentation is written in Microsoft Word and Microsoft Excel.