Regulatory Affairs and Quality Management
REGULATORY MANAGEMENT Successful regulatory submission is a prerequisite for gaining market approval. Approved regulatory submissions for medical devices require explicit adherence to specific content and format requirements since every regulatory agency has unique requirements, and those complex requirements often change. Regulatory communications with the appropriate authority staff members may even be necessary for timely approval […]
Product Labels and Packaging
Labels and Packaging More than 50% of recalls are related to the labeling or to the packaging artwork. The accuracy of your labels and packaging is mission critical. Without it, recalls occur. People get hurt. Company’s reputation may be irreparably damaged. Medical companies increasingly face a wide variety of labelling and packaging challenges. These may […]
Product Development
Product Development MedXFile designs, develops, tests and validates software and hardware products for the medical device industry. With expertise in software, mechanical and electronics engineering, our team accelerates your time to market with solutions for your medical device needs. Our scientific approach and process support all stages of the product lifecycle. New Product Development from ideation […]
Technical Writing and Training
e-Learning Excellent training programs increase customer satisfaction and reduce the learning curve. This requires careful development to meet your audience’s needs and encourage knowledge retention. However, writing for the audience is a complex task requiring product and end user understanding. At MedXfile, we lead every step of the instructional design process, from concept, storyboarding, scripting, […]