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​On February 2, 2024, the FDA officially announced its plans to amend 21 CFR Part 820 to align more closely with ISO 13485—the globally recognized standard for medical device quality systems. While many OEMs already follow ISO 13485, those who don’t will now have until February 2, 2026, to make the transition. Here's what you need to know about the shift, what’s changing, and how to prepare.

Our client, a Class III medical device company, was issued an FDA 483 warning letter due to product field failures and QMS issues posing life threatening risks to implant patients.

The Square-1 Engineering subject matter experts (SME team) were brought in to identify & correct systems and process issues across six (6) functional departments and two (2) manufacturing  locations domestically.  As you can guess our clients’ situation was dire due to several implant failures in the field.

We invite you to download the case study below to learn how we saved our client $4.5M while successfully concluding the remediation project.

As a consultant [freelancer, gig, moonlighter, etc.] we work in the capacity of ‘work for hire’ whereas we go in, do a job and work ourselves out of the picture.  Then it’s onto the next job, rinse and repeat.  This can be a fun way to make dough while providing that good ole ‘work life balance’ so many people love to preach about.
 
Where consultants typically run into problems is the work they’re performing on behalf of the client or end user isn’t clearly defined or even in writing.  As a result, it’s common for consultants to find themselves in sticky, even legal, situations they don’t know how to navigate.
 
Keeping your nose out of legal issues or poor project results really comes down to ‘deliverables’, however before we get there it’s important we keep top of mind two maxims which are the cornerstones of a consultants life:
 
Know what you can do vs what you shouldn’t
(don’t try to be everything to everyone, stay in your lane doing good quality work you’re confident you can deliver)
 
Remove the he said she said situation
(both consultant and client should sign a Statement-of-Work, SOW, which clearly spells out responsibilities of each party, cost, duties within the project and their respective deadlines, these are referred to as ‘deliverables’, before the project starts)
 
Establishing deliverables with a client can be tricky.  It’s important both parties agree on the expectations of the work to be performed and the consultant can actually deliver the goods.  Remember, the SOW is a legal document.  If you over commit and under deliver you could find yourself in hot water. 
 
If you’re a consultant and are establishing deliverables on a project with a client make you keep the following in mind:
1. Can you deliver what the client expects and are those expectations realistic?
2. Challenge the customers’ expectations – does the customer understand what they want and does it match up with what they’re asking? 
3. Communicate ahead of time – if you need help, are missing info or are at risk of missing a deadline, don’t wait till the very last minute to communicate.  At the first point in which the issue arises inform your client of the situation and in the same conversation come prepared to offer a solution.  Communication is key to successful project completion.
4. Focus on performing at a high level while delivering early, this will position you to be awarded more business in the future from said client
 
Key Take Away:
Get all work agreed upon in writing via an SOW and ensure you can actually deliver the goods.  Communicate in the moment and often while focusing on delivering ahead of schedule with a high level of quality output.

​Action Item:
Run a gap analysis on your existing projects to see if there are areas you may be at risk.  Once you’ve identified those areas of risk on your current projects, come up with a viable solution to address it and proactively communicate with your client the situation and next steps.  Ask for their buy in, then move forward.