Our firm has more than 30 years’ experience working with medical device companies as they prepare for interactions with the Food & Drug Administration (FDA). We have assisted in submitting new product for FDA review, prepared organizations for upcoming changes in FDA regulations, represented companies during FDA audits, and developed regulatory strategies to ensure compliance.
We’ve found that teams are often anxious in advance of FDA interactions. Whether it’s a routine audit or a submission for review, the process can appear byzantine and intimidating. But it doesn’t have to be. FDA regulations provide guidelines to ensure patient safety, and following a few basic rules and common sense can go a long way.
Quality Systems Consultants has extensive history preventing and resolving complex compliance issues. We have a stellar reputation, previously voted #7 out of 100 by Quality Magazine for continuous improvement to quality systems and contribution to bottom-line profitability. We’ve helped with:
- Document control;
- Compliance resolution;
- Training;
- Audits and reviews;
- Nonconformance review;
- Traceability; and
- Much more.