Totally delegate this.
Want to be more productive?
You totally shouldn’t be doing any of the things on this list.
That is, unless you enjoy staying current on every regulatory, quality, and compliance detail in this new-guidance-every-other-week world we’re in.
No, in fact, I take it back. There’s no “unless” here.
If you’re spending time on these details, you’re not spending enough time on the big picture.
Let me take care of these for you. Most clients do.
Listed by frequency of request, here are the ten technical support services my team provides most often:
- Design control documentation – Everything you need to be compliant with design and development regulatory requirements, including design inputs and outputs, design reviews, design transfer, and more.
- Risk management – This design control process subset works to assess risk to the patient, the user, and degraded performance; includes a mitigation and control plan.
- Usability – This risk management process subset, works to help deliver a safe and effective device that meets user needs. We can write the protocols for you.
- Requirements management – This design inputs subset works to state design inputs and user needs in a verifiable and complete way.
- Management reviews – The quality management system (QMS) review to determine performance versus key indicators including product performance.
- Engineering protocols – The plan you establish before testing that verify design requirements and inputs.
- Quality agreements – Agreements with suppliers that explain who’s responsible for fulfilling each regulatory requirement.
- Internal audits – Mandatory self-assessments of QMS performance.
- Supplier audits – Kinda the same thing, this time for your suppliers, and includes assurances their QMS controls are appropriate for your product. You can send us to your suppliers to conduct those audits.
- Regulatory education and training – The education you need to understand the requirements and your QMS. I also provide one-day, topic-specific trainings on design controls, use cases; that sort of thing.
Blah blah blah blah blah blah blah.
You don’t need to read any more on this topic.
Delegate technical support to me or someone else.
This is a binary choice. Pick one:
- You’re right, Michelle. I should offload our technical support. We shouldn’t be doing it.
- I should offload our technical support, Michelle. You’re right, we shouldn’t be doing it.
Let’s get you focused on your critical regulatory path, yes?
+ Michelle +