Jul — 2022 Compliance Flash: Physician Owned Distributorship Physician Owned Distributorship Read Article
Jun — 2022 Compliance Flash: Single Use Devices Re-use of Single Use Devices can put physicians and manufacturers at risk for health care fraud and adulteration. Read Article
Jan — 2022 Risk Management is critical to establishing a positive benefit: risk profile and ensuring the best possible patient outcomes. By: Peter Bowness Director, International Regulatory Affairs Read Article
Mar — 2018 Medical Device Quality: Why Software Is More Challenging Than Hardware The U.S. read article
Feb — 2018 The Impact of U.S. Regulation on Medical Device Innovation Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators. read article
May — 2017 Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel For a company navigating a Class III medical device’s path to market, the U.S. read article
Aug — 2016 Four Questions to Help You Avoid Losing a CE Mark A Clinical Evaluation Report (CER) is part of the process through which a medical device is certified or recertified to carry the CE mark; it appli read article