You Should Totally Delegate Regulatory Affairs and Quality Assurance Matters.
Want to be more productive?
You really shouldn’t be doing any of the things on the list below.
You can’t effectively manage your business while staying current on every regulatory submission, quality assurance, and medical device compliance detail in this new-guidance-every-other-week world we’re in.
And if you’re spending time focusing on these details, you’re not spending enough time on the big picture.
Let us take care of the regulatory strategy stuff for you. Most clients do.
Top Ten Things You Don’t Need To Be Doing.
These are just a few of the technical support services my team performs EVERY DAY for clients just like you:
- Quality System Remediation
- Technical Dossiers
- Quality System Development
- Unique Device Identifier (UDI)
- Label Design
- Risk Management
- Biocompatibility Testing/Sterility
- Method Validation
- Breakthrough Device Designations
- Cybersecurity/Artificial Intelligence/Machine Learning
Yay – My Product Is Cleared and the Hard Part Is Done!
Except it’s not.
You’ve still got to assess, implement, and maintain a compliant quality management system (QMS) – it’s a living, breathing, use-every-day system that requires careful tending.
And once you’ve got the maintenance part under control – look over there! Here comes another changing regulation for the FDA or other notified bodies.
Not to worry. We’re buds now, so we can study the new regulations, guidance documents, and technical documentation standards for you.
Then, we can create the appropriate transition and implementation plans on your behalf.
You go focus on growing your business – we’ve got this.
Free Your Mind. The Rest Will Follow.
We’re still not going to put you on a meaningless, third-party email list and try to sell you all the time.
But, if you need our help – and you probably do – well then, we’re going to need a few pieces of information. It won’t hurt, I promise.
Remember – delegation is the hallmark of savvy CEOs who know how to hire the right people for the job. A lot of established companies delegate their quality management system and regulatory affairs tasks to external consultants.
So, go ahead – click the button below, and free your mind to concentrate on big-picture stuff that only you can do.
Regulatory Affairs and Quality Assurance Got You Down? Delegation, Delegation, Delegation.
You may be an entrepreneurial superhero, but you can’t do everything. Nor should you – it’s counterproductive.
So pick an open half hour on my calendar and we’ll chat.
