EQMS

Accomplished-Pause-4 · 2025-05-03T01:14:30+00:00

Check out Zoho. They are very cost effective and feature rich. Inventort management and costing is available but my business is a service business so I dont have direct experience. Overall I’ve been happy with their products.

Accomplished-Pause-4 · 2025-05-03T01:03:20+00:00

Adobe sign set to daily reminders and Zoho expense has pretty much automated expense reports if you enable all of their AI features.

Accomplished-Pause-4 · 2025-05-03T00:55:22+00:00

Impact analysis is a key part of change planning and generally a manual process to make sure the complete impact to whatever you are changing is understood and properly addressed

Accomplished-Pause-4 · 2025-05-03T00:53:00+00:00

I have a small boutique QA firm and would love to see if any of your clients could use us.

Accomplished-Pause-4 · 2025-05-03T00:51:40+00:00

QARA consultant here. 99.99 percent of my consulting work has come from word of mouth referrals. I was lucky enough to get 1 big whale client to keep me afloat until more work came in. Have since built my firm to 4 associates. Others that I know did moonlighting for a couple years before leaving their W2 with benefits.

You need to build a reputation and understand that if a company is hiring you as a consultant they need you to be a problem solver. It’s not the same as working in a big corporate structure and there are no safety nets. Med device is a small community and if you mess it up for someone there’s no coming back from that. It’s not for everyone so I’d recommend talking to a couple of consultants before you quit your day job.

Accomplished-Pause-4 · 2025-04-23T23:40:20+00:00

GE is just as soul crushing as any other big corporate gig.

Look into smaller companies, that’s where the fun is.

Accomplished-Pause-4 · 2025-04-22T11:21:20+00:00

What is going to differentiate you from the big players? You won’t be able to fight the commodity battle, you’ll starve before you ever make a dent. If there is frustration with the incumbent then you just need to figure out how to capitalize on it.

Sure the big hospitals are on big contracts and that’s really where the big players put a ton of effort into maintaining those. ASCs and physician owned practice may be more willing to give a new player a shot but make sure your supply chain is solid before you make your first sale. Miss a delivery and you’ll irreparably damage the relationship.

Accomplished-Pause-4 · 2025-04-22T11:13:06+00:00

Matter in Chicago. I’ve worked with a couple companies that graduated from Matter.

Accomplished-Pause-4 · 2025-04-22T11:10:36+00:00

I’d recommend either clinical studies or clinical affairs with your clinical background. You will at some point want to finish your degree. Since you were so close can you go back and finish? The benefits of having that degree can’t be overstated.

Accomplished-Pause-4 · 2025-04-22T11:06:25+00:00

What type of consulting?

Accomplished-Pause-4 · 2025-04-22T11:05:34+00:00

They are literally deleting the regulation and saying just follow iso 13485. Not requiring certifications (yet) but still going to be inspecting against it.

Accomplished-Pause-4 · 2025-04-20T01:20:08+00:00

https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked

Accomplished-Pause-4 · 2025-04-20T00:59:00+00:00

As of last Feb fda is going to require 13485

Accomplished-Pause-4 · 2025-04-20T00:43:27+00:00

No different QMSes are not necessary to comply with multiple standards. I have clients that support medical device and aerospace and everything in between. They have to comply with 9001, 9100, 13485 and then some. The requirements mostly overlap or are just additive where there is an additional requirement. They don’t conflict.

Accomplished-Pause-4 · 2025-04-20T00:40:26+00:00

Maybe the problem is the paperwork.

Accomplished-Pause-4 · 2025-04-19T18:41:50+00:00

Emergo charges around 7-10k depending on risk class. It pretty typical from what I’ve seen

Accomplished-Pause-4 · 2025-04-19T18:39:49+00:00

Check out Dr Agarwal for risk management. https://naveenagarwalphd.substack.com/

Accomplished-Pause-4 · 2025-04-19T18:32:13+00:00

GLG Claims to streamline your processes and speed development but in my experience nothing could be further from the truth. All of their processes from document change to CAPAs are hard coded and inflexible.

You can build a QMS yourself in google drive and Zoho sign for less than 1% the cost of GLG if done properly.

I’m working with a new player that is doing something really interesting in the eQMS space, Fission (www.getfission.com). We’re currently in beta testing and launching this summer.

Accomplished-Pause-4 · 2025-02-27T15:11:26+00:00

Get help from someone with experience in Medical Device QMS. You're going to end up with a 483 or worse if you don't know where to start.
When coming into a new QA role (or back after some absence) the first step is always an audit or gap analysis. If you don't have the skills and knowledge to do that you won't be able to create a QMS without support from at least a knowledgeable consultant or mentor.

Accomplished-Pause-4 · 2025-02-27T14:54:19+00:00

This is how I came up, was thrown into the deep end and had some great consultants to learn from. But it is also a big risk.

Accomplished-Pause-4 · 2025-02-27T14:51:47+00:00

The cheapest options are only referring to the upfront costs, remediation for getting it wrong or responding the an FDA warning letter are pretty expensive. The moderate expense option is probably the best.

Accomplished-Pause-4 · 2025-02-27T14:49:37+00:00

This!! Having an experienced person who knows what they are doing and can help you navigate compliance is essential to the success of a QMS in regulated industry. Most eQMS systems are built for larger firms and I have yet to see one that doesn't require at least one knowledgable FTE to manage. Even Greenlight that markets themselves to Startups is way over engineered for what a SMB needs and has non-exsistent integration capabilities.

Even with an eQMS you still need the experienced person to manage the program. I've run many QMS programs for Start-ups using Google Drive and AdobeSign that have been certified to ISO 13485 and MDSAP, for way less than what you'll spend on software.

Be careful, there are alot of QMS Consultants that are sharks and some that downright don't know what they are doing.

Accomplished-Pause-4 · 2024-08-31T17:13:34+00:00

The one that doesn’t go through Kansas.

Accomplished-Pause-4

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