Do you have a Quality System? Does it work for your company's
business? Are you considering ISO compliance? We write, rewrite, and
implement Quality Systems that work as Business Systems too. We make sure
that the quality system is "right sized" to fit your business yet be
Does your product require Pre-Market Notification (510(k) or
Pre-Market Approval (PMA)? Do you intend to sell outside the USA? We can
help with obtaining Agency approvals.
- Software Validation
- Do you use software in your business or product, and if so is it
validated? It's a requirement and we have the expertise to help. The FDA says that "Software is Different" and mandates validation for
pretty much all of it. It turns out to make good business sense too.
Want or need to do a clinical study? Want to see it published or to use the
data for a submission? You'll need to know about IRBs, Informed Consent,
HIPPA, Monitoring and data analysis.
You've got an idea but need it turned into a prototype. Your
products have failures and you don't know why or what to do next. You want
an unbiased technical expert to participate in a design review. You've come
to the right place.
- Agency "Issues"
You had observations from your last FDA inspection. You received a warning
letter and don't know where to go next. You've been put on the AIP list and
need help formulating a strategy. We've helped others and can help you.