Ombu offers comprehensive services that help medical device manufacturers satisfy operational and regulatory requirements.
Effective medical device manufacturing requires a combination of regulatory understanding and operational implementation. Ombu brings that combination to your projects. We have a solid understanding to FDA regulations and ISO 13485 that we combine with modern quality methods, including statistical and operations management techniques.
If you need to validate a process, we can help you implement the regulatory requirements including FDA and Global Harmonization Task Force guidance documents. To demonstrate compliance, you should apply statistical methods including both acceptance sampling and statistical process control. We have the skills and techniques to help you complete your project on time.
We can help you implement an effective approach to complaint handling. This is a major focus for the FDA and one of the more frequent citations on FDA 483s. We can help you develop and implement and effective systems that complies with the interlocking regulatory requirements for complaints, CAPA, MDRs, Servicing, and Corrections & Removals.
CAPA system deficiencies are frequency cited by the FDA. We can help you implement a CAPA system that drives continuous improvement, and its consequent cost reduction, and conforms to the regulatory requirements.
Many companies perform acceptance sampling, often using ANSI/ASQ Z1.4, but don’t apply it correctly. In addition, the standard has opportunities to reduce inspection cost, but many companies don’t take advantage of them. The c=0 plans offer reduced sample sizes, but pay a penalty of increased lot rejections. We can help you evaluate your sampling choices to achieve the right balance between protection and cost.
Risk management should employ a life cycle approach instead of a static analysis in the design phase. We can help you implement ISO 14971:2007, but more importantly, integrate it with you complaint and CAPA system to keep the analysis current and help reduce the risk of device problems.
The examples above describe some of our skills and capabilities, but are not comprehensive.
Our approach is project oriented, working with you to set the scope, deliverables, and timing of the project. We can provide MS Project plans as well as regular status reports.
To discuss your projects and how we can aid in your improvements, please contact: