FDAnews Device Daily Bulletin

As devicemakers work with increasing numbers of suppliers, their risks of liability rise, making it imperative they have contracts and auditing policies in place to avoid costly lawsuits, recalls and adverse publicity, a product liability expert says. Most device companies don’t have formal contracts with suppliers, working instead under purchase order terms and conditions that can be one-sided and vague regarding who is liable for product recalls or who should deal with regulators when issues arise, said Sara Dyson, assistant vice president of loss control at Medmarc Insurance Group.
International Medical Device Regulatory Monitor