Clinical Nurses as an option to reduce FDA Audit observations
Clinical Nurse Consultants (Medical Device Clinicians) in the Medical Device Field to help reduce FDA Audit Observations and facilitate EU MDR compliancy
By: R. Edwards, RN, MSN
Nursing Consultants are valuable to medical device companies when advising on strategic planning, value-based care strategies and governance. Adding a nurse to any regulatory process makes good business sense as they bring credibility to data as registered nurses are bided by ethics and principles in their practice discipline.
In most states, a nurse is required to have at least a Bachelor’s degree to practice their discipline. In addition to their education and experience in a healthcare setting, nurses come with the clinical knowledge and hands on experience with many devices.
Utilizing a registered nurse can help reduce FDA audit observations, especially those surrounding adverse event assessment and the usability of these medical devices. Nurses can also satisfy EU-MDR regulatory needs by authoring Clinical evaluation plans (CEPs), clinical evaluation reports (CERs) and Post Market Clinical Follow-up (PMCF) Plans /Reports.
Certain sections of the regulations require that individuals have applicable healthcare licenses and it makes sense to hire a nurse over an MD because of lowered costs.
Below are a few jobs in which nurses have been in increasingly high demand:
CER Report Writer
Medical Writer
Complaint Analyst
Medical Complaint Handler
Post-market Surveillance Specialist
Quality Complaint Specialist
The Oxenham Group maintains a RN Program Manager and a bench of 12-15 nurses that are readily deployable to support medical device companies across the country. We offer extensive and customized training to rapidly assimilate our staff and ongoing check-ins and performance reviews, conducted by our Program Manager.
If you are interested in learning more or viewing our pipeline, please email info@oxenhamgroup,com or call (605) 610 3026