Do you work for a manufacturer of medical devices? Are you worried about an upcoming audit? Have you struggled to get some quality issues under control? If so, I would love to help you, because for the past couple years I have helped companies plan and implement Quality Management Systems so they can develop and continually sell safe and effective devices. My approach is tailored to your team to help them understand not just standards and regulatory requirements but also the underlying culture and organizational behaviour that affects decision-making. Why do I not just focus on the standards and regulations? I believe that a holistic approach helps eliminate root causes of systemic issues that lead to staff turnover, stalling productivity, and loss of institutional knowledge, which often lead to or exacerbate problems like complaints, CAPAs, and recalls. Alongside me are a team of expert consultants at Akra Team who can help you with all things clinical, regulatory, and quality related. Message me here or email me at lawrence.yeh@akrateam.com, and follow me on LinkedIn!