Since 2010, LeanRAQA has supported 100+ companies with regulatory strategy and submissions, audit preparation and remediation, quality systems compliance, due diligence, technical support services, and grief counseling – because dealing with regulators can be emotionally draining. Delegating all those things to LeanRAQA can help you focus on winning in the marketplace.
FDA | MDR | MDD | GMP | ISO:13485 | ISO:14971 | Risk Management |
Please find many interesting topics and regular updates on LeanRAQA’s YouTube channel!
Risk Management with Edwin Bills
No matter the risk management question, Edwin Bills will likely have the answer. He’s been involved in the medical device quality and regulatory space for many, many years. Give him a tricky compliance situation or example, and chances are he has been there and done that – probably more than once. Ed sat down with Michelle to talk about ISO 24971, MDR and the risk of radiation exposure in a sun-filled hospital room. (June 3,2021)
How FDA Product Registration Pays Off in the Long Run
Does the idea of your product falling under the FDA purview keep you awake at night? Does the very thought of the process send your ulcer into overdrive? Take heart, weary viewer, because it is possible to have a positive FDA experience – as long as you are fully prepared. (May 20,2021)
Notified Body Questions You Should Be Asking
Is your notified body up to the task for your medical device? Michelle Lott breaks down the yes/no questions you need answered today! (July 2,2019)