FAQs

With any purchase, you are provided with up to 20 hours of free customer-support phone service. All CS representatives are certified, experienced Quality and Regulatory professionals. Additional customer-support hours are available at an hourly rate. In addition, we also provide native Spanish speakers for our Spanish-speaking clients.

Yes. Quality System Modelers products are provided in fully editable templates with suggested content. You can edit completely, as you see fit. You can also use the flowcharts that demonstrate the interaction between all elements of the products so you can determine which are most appropriate for your specific business infrastructure and objectives.

All solutions provided by Quality System Modelers are compliant with U.S. FDA Medical Device GMPs and 21 CFR regulations. In addition, the medical device industry solutions are also compliant with ISO 13485, EU MDR 2017|745 and EU MDR 2017|746 directives. Finally, applicable guidance documents (U.S. and EU) were also used in the creation of the solutions including the MDCG. As additional industries are added (e.g., pharm, combo, and bio products), the solutions are being developed to include compliance with additional FDA, ISO, ICH regulations, EU directives, standards, and guidance documents.

Quality System Modelers provides turnkey solutions that can be downloaded and used as you see fit without the high cost of traditional consulting companies. Since these turnkey solutions are developed with the highest risk products in mind, they contain all information required for high risk products. Lower risk product manufacturers may easily remove those elements that are not applicable to their operations.

Currently Quality System Modelers specializes in the medical device manufacturing industry (all classes) but will be adding products and services to support pharmaceutical, combination products, and biologics soon.