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Available ISO 13485 Consultants

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dsanabria

Quite Involved in Discussions
#12
If you are a consultant in implementing ISO 13485 and would like to advertise your availability, please use this thread to post anything you would like to promote your services. I suggest a link to a web site and/or a brief profile - some basic information.

My basic expectation if you do this is that you be a regular, active participant in the forum, that you are a forum Contributor and that you are helping others here. I will delete any one-shot Nellies who come, post their advertisement and are not active in helping others.

Of course, I always appreciate your considering me as your implementation resource.

NOTE: Your post count must exceed 150 *HELPING* posts to post in this thread. (Posts that are questions do not count)

We prefer that those who post here participate by helping with answers to peoples questions on a somewhat regular basis in addition to post count. I think that is only fair for free advertising.

You might also note that if you do not read and abide by these requirements to post in this threa, and you do post in this thread, you will be advertising yourself as a "clueless" (and therefore very undesirable) "consultant". Who would want a consultant who can not read and understand the requirements? Your post, of course, will be deleted.

Marc

What about AS91XX and ISO 9001 consultant... :))
 

Sam Lazzara

Trusted Information Resource
#14
My solo consultancy is geared towards startup medical device companies preparing for quality system lift-off. The focus of my work is to deliver customized, world-compliant, lean, paperless quality system document sets based on what I have learned in my 35+ year career.

After day-jobs at 7 firms for 26 years, I transitioned to full-time consulting in 2009. Since then, I have helped over 60 medical device firms set up or renovate their quality systems. I offer a "Full Document Set" that covers all life-cycle stages and a "Startup-Pack Document Set”. The Startup-Pack includes procedures needed for product development work to support initial regulatory authority submissions but does not include procedures needed to support device human clinical investigation or commercialization.

My tailored document sets provide a solid foundation for quality system implementation, whether starting from scratch (preferred) or renovating an existing system (ugh).

After delivering the document sets for a fixed price, I provide consulting services for strategic advice, implementation support, regulatory requirements training, internal quality audits, and independent design reviews (required by the USA FDA).

Caution: I do not have the bandwidth to run my clients' quality systems. The client will need to appoint a Quality System Management Representative and functional group managers (R&D, QA, RA, Marketing, Operations, etc.) who use the system to guide their activities, combined with their own experience, common sense and technical/business decision-making skills. As a consultant, I will coach and mentor team members as desired.

For more information about my work, my opinions, and my services, please visit MDQC.com
My resume, including my client listing, is attached.
 

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