Services
How can we help you?
Establishing the right-sized quality management system to enable your medical device company to grow and achieve its goals is my priority. Whether you’re a new startup looking for a basic quality management system as a starting point or if you’re further on in your journey and require an upgrade to prepare for an upcoming audit or inspection we can get you there. See detailed services…
Regulatory Compliance Strategy
While 100% compliance with applicable regulatory requirements should be part of any medical device company’s quality objectives, achieving this state is often an ongoing journey. The regulatory landscape can be difficult to navigate and where multiple options exist for compliance we are there to put our medical device industry experience to work for you to develop a risk-based compliance strategy to keep your organization on track with its goals.
Quality Engineering
Provide quality engineering expertise at each stage of your medical device product’s life cycle and advise on specific activities such as design history files, design inputs, design outputs, specification development, risk management, design verification, design validation, inspection plans, process validation, statistical process control (SPC), and much more.