Why Do You Need Fractional Medical Device Quality Assurance Services?
Well, let us tell you exactly why!
Perhaps you’re a startup or a small to mid-size company and you understand the practice of hiring a fractional CFO because you don’t need (or can’t afford) one full-time.
Most likely, this fractional CFO has extensive C-suite experience, and signs on temporarily to help you establish compliant accounting and billing practices and to guide your strategic financial decisions until you are ready for a full-time hire.
Fractional medical device quality assurance works much the same way.
Hire the leanRAQA team, and we’ll make sure you remain compliant by performing those routine maintenance tasks; the routine maintenance tasks that you need to do but don’t have the time – or the skillset – to do.
Fractional quality assurance Is a great way to get the expertise you need without breaking the bank – a huge help for companies vying for capital while simultaneously developing and launching a product.
What Can Fractional Medical Device Quality Assurance Services Do for You?
Quite a lot, actually – namely taking the stress off you and your staff by performing these routine quality management system maintenance tasks: (Spoiler Alert: Some of these activities can’t be outsourced.) These tasks need to be done AT LEAST once a year (unless your quality management system has some very creative justifications) but we know you don’t have the bandwidth to worry about whether you’re compliant. That’s where we come in.
You Can’t Outsource Management Responsibility. But You Can Delegate the Routine Tasks.
Though you can outsource quality activities, you can’t outsource management or executive responsibility for quality.
The quality buck stops with YOU, Ms/Mr CEO.
Even if you purchase an electronic quality management system, you are still ultimately responsible for the quality culture of your organization – and the quality of your products.
Quality management activities should not be stressful. But too often the quality procedures are written, then sit collecting dust while your team scratches their heads trying to figure out how to implement them: What content needs to go into management review? Where do we find an internal auditor? Do they need special qualifications? How do we qualify a supplier? How do we know if this supplier quality agreement is good enough?
Our fractional quality assurance services take the guess work out of compliance because we KNOW what information is required in a management review, we KNOW when to open a SCAR, and we KNOW when to complete performance reviews.
You can feel secure knowing you’re working with knowledgeable, experienced medical device quality assurance consultants and enjoying the benefits of the same level of expertise you’d get from a full-time senior level employee–without paying for a full-time senior-level employee.
Strategy Got You Stumped?
Download my FREE Business Market Assessment tool which walks you through the revenue vs. cost modeling calculations that can help you judge the market viability of your product – before you commit.
Then pick an open half hour on my calendar and we can chat about the best submission strategy for your product.
