MEDICAL DEVICES

Medical devices are becoming increasingly more sophisticated. What were once individual devices interacting with a single patient, are now storing and transmitting data, contain configurable systems and are connected to larger networks.

JENLO Compliance assists manufacturers in understanding and complying with all aspects of FDA, European Commission; EU Competent Authorities and Notified Bodies, as well as other global authorities in complying with all requirements. Whether it involves development, approval and clearance, manufacturing, marketing, or post-market reporting and field actions in each of those jurisdictions JENLO can help you.