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!!!
ISO 9001 System™ is specifically designed to meet the ISO 9001 standard. Achieving ISO 9001 certification recognizes your company as a worldwide leader in customer service...[Read more] [Download now for US $299] [Free samples: Quality Manual | Management Review Procedure | Guide Book]
ISO 9001 + CE Marking System™ is specifically designed to meet ISO 9001 and CE Marking standards. Achieving ISO 9001 certification recognizes your company as a worldwide leader in customer service. CE Marking is required by EU for products and services entering the European marketplace...[Read more] [Download now for US $529] [Free samples: Quality Manual | Management Review Procedure | Guide Book]
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...[Read more] [Download now for US $499] [Free samples: Quality Manual | Management Review Procedure | Guide Book]
FDA QSR + Risk Analysis System is specifically designed to meet FDA QSR regulations 21 CFR Part 820 , ISO 14971 standard for conducting FMEA’s. 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. The Risk Analysis section contains Procedures and Spreadsheets for conducting Failure Modes Effects Analysis...[Read more] [Download now for US $529] [Free samples: Quality Manual | Guide Book]
FDA QSR + ISO 13485 + CE Marking + CMDR System™ is specifically designed to meet FDA QSR and ISO 13485 , ISO 14971 , EN 980 , Risk Analysis , CE Marking , MDD 93/42/EEC standards, Health Canada SOR 98/282 and Australian regulations. 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. CE Marking is required by EU for medical devices entering the European marketplace. Also meets Canadian and Australian Medical Device Regulations. Your company’s quality system will meet FDA and International medical device manufacturing and servicing standards...[Read more] [Download now for US $629] [Free samples: Quality Manual | Management Review Procedure | Guide Book]
ISO 13485 + CE Marking System™ is specifically designed to meet ISO 13485 , ISO 14971 , EN 980 , Risk Analysis , CE Marking and MDD 93/42/EEC standards and regulations. CE Marking is required by EU for medical devices entering the European marketplace. Also meets Australian Medical Device Regulations. Your company’s quality system will meet international medical device manufacturing and servicing standards...[Read more] [Download now for US $549] [Free samples: Quality Manual | Management Review Procedure | Guide Book]
ISO 13485 + CE Marking + CMDR System™ is specifically designed to meet ISO 13485 , ISO 14971 , EN 980 , Risk Analysis , CE Marking , and CMDR standards and regulations. CE Marking is required by EU for medical devices entering the European marketplace. Also meets Canadian and Australian Medical Device Regulations. Your company’s quality system will meet international medical device manufacturing and servicing standards...[Read more] [Download now for US $599] [Free samples: 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.