For companies in FDA-regulated industries, ensuring the highest product quality and adhering to regulatory compliance is both complex and necessary. Makromed is a group of experienced professionals dedicated to help such companies. We provide QMS Software Solutions and Consulting Services to customers ranging in size from startups to Fortune 500 companies. Makromed is ISO 13485:2016 registered, keeping us aligned with our customers’ quality objectives. “We Practice what we Preach.” What do we provide? Software Solutions: Makromed develops QMS software that address various requirements of FDA’s QSR/GMP regulation, EU’s MDR, and international quality standards. These include: • InfoPV – Process/Test Method Validation • InfoSQA – Software Validation • InfoMed – Complaints/Adverse Events • InfoCAPA – Corrective/Preventive Action • InfoAudit – Internal/Supplier Audits • InfoTrain – Employee Training Consulting Services: We offer our expertise on various regulatory topics. Our focus is on the activities that revolve around new product development and introduction. We will work with your technical staff on product design, testing, evaluation, regulatory approvals, and documentation including projects like: • Process and Test Method Validations • Software Validations • Risk Management • Statistical Techniques / Biostatistics • Design Controls – DOE / Reliability • CAPAs / Six Sigma Tools • QSR / MDR / ISO 13485 Audits and Training • 510(k) and De Novo Submissions on software-driven devices MyFDAAcademy.com E-Learning Center: For expertise on FDA-related Quality, Regulatory, and Compliance areas, we offer e-learning at www.MyFDAAcademy.com. There you can partake in interactive and immersive online training on QMS and RA topics. For more information on what we can do for you, please visit our website at www.makromed.com or email us at info@makromed.com to discuss your needs or to schedule a demo of any of our products.