When manufacturing a medical device, stringent standards and regulations must be followed to meet regulatory requirements. Engaging in the services of a medical device consulting company offers manufacturers expert advice and up-to-date information on the global medical device industry. Medical device consultants will have extensive experience into FDA, EU, MDR, Japanese MHLW, Korean MFDS, and other regulatory expectations globally.
Toxicological Risk Assessment
Medical device consulting companies provide toxicological risk assessments. This is a vital step in evaluating the device’s safety. As specified in ISO 10993-17, there are limits for leachable substances found in the chemical characterization of a device. An experienced consulting company will provide assorted services to support biocompatibility projects.
Chemical Characterization
Medical device manufacturers should have their devices chemically characterized. This is an essential part ofgaining regulatory approval. A leading medical device consultancy firm will provide valuable guidance and expertise in this area. Their extensive knowledge will establish a streamlined process when seeking chemical characterization.
Patient Safety
Standards must be met, and regulations followed to ensure patient safety. If a medical device were to contain impurities or leach hazardous chemicals and substances, this could potentially cause harm to the user. The patient could suffer from adverse reactions or medical complications. Manufacturers should look to consulting firms with experience, expertise, proven success, and industry-leading turnaround times, with patient safety as their key objective.
