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Available ISO 13485 Consultants

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Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
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Howard's
International Quality Services


Marcelo Antunes'
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Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
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Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

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NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


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consultants and consulting, iso 13485 - medical device qms
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  Post Number #1  
Old 17th June 2014, 05:25 PM
Marc's Avatar
Marc

 
 
Total Posts: 26,668
Thumbs up Available ISO 13485 Consultants

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.
Thank You to Marc for your informative Post and/or Attachment!

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  Post Number #2  
Old 17th June 2014, 06:11 PM
DannyK

 
 
Total Posts: 677
Re: ISO 13485 Consultants

Marc,

Thanks for the opportunity!

Docusys Corporation, based in Montreal, Quebec, Canada has been assisting companies in implementing and maintaining medical device QMS ( ISO 13485) for many years. Besides being a consultant, Danny Kroo is registered lead assessor for ISO 13485, CMDCAS and MDD with BSI.
We implement simple quality systems that are economical and easy to maintain.
We have local and international clients providing documentation, implementation, training and regulatory affairs consulting services.

Please do not hesitate to contact us through our website if you have any questions our comments.

Please visit www.docusys.ca
  Post Number #3  
Old 18th June 2014, 05:53 PM
Ronen E

 
 
Total Posts: 3,736
Re: ISO 13485 Consultants

Hi all,

Please feel very welcome to send me a private message if you need help in setting up / upgrading / auditing an ISO 13485 QMS. I offer on-site, in-person service in Australia/NZ and southeast Asia; other than that I'd be glad to assist remotely and/or provide desktop audits / reviews.

I've been in the medical devices / pharma industry for >15 years, including R&D, engineering, QA and regulatory affairs. I've been independently consulting and assisting entrepreneurs, start-up companies and established manufacturers since 2005. Please browse my Elsmar Cove posts to get an impression.

Cheers,
Ronen.
  Post Number #4  
Old 18th June 2014, 08:02 PM
yodon

 
 
Total Posts: 1,169
Re: ISO 13485 Consultants

Would also like to express thanks for the opportunity!

We have more of a niche 'market' for 13485 consulting. Our primary business is contract R&D; however, we frequently get clients asking for device development and then they learn that they need a Quality System even though they are outsourcing essentially everything. So we're primarily marketing these services to the virtual company. And the Quality System is reflective of such a company. We don't sell a "canned" system - we'll work with you to ensure it fits the culture, etc.

We'd be more than happy to discuss any such needs. Either send me a private message, contact us through our website (www.therealtimegroup.com), or send an email to sales@therealtimegroup.com.

Last edited by Ajit Basrur; 19th June 2014 at 09:05 AM. Reason: fixed weblink
  Post Number #5  
Old 1st November 2016, 02:56 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,219
Re: Available ISO 13485 Consultants

I would like to introduce my Claritas Consulting, LLC. Based in Massachusetts, we collaborate with clients representing medical device, pharmaceutical (includes formulated product like oral solid dosage forms and sterile formulations, active pharmaceutical ingredients and excipients), combination products, cosmetics and laboratories in the quality management systems to help them achieve and maintain the compliance levels.

With an experience of over 25 years, we design / suggest improvements in a quality system to meet regulatory and customer expectations to cover 21 CFR Part 210/211, 21 CFR Part 820, ISO 9001, ISO 13485, ISO 17025, and ISO 15378 requirements. In addition, we perform internal and supplier audits, perform gap analysis and devise a plan to fulfill the requirements, and provide solutions on interpretation and implementation of the regulations and standards.

Please drop me a private message if you have any questions.

Thank you !
Thanks to Ajit Basrur for your informative Post and/or Attachment!
  Post Number #6  
Old 1st November 2016, 09:47 PM
Ronen E

 
 
Total Posts: 3,736
Re: Available ISO 13485 Consultants

Good luck Ajit!

Ronen.
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #7  
Old 2nd November 2016, 11:55 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,219
Re: Available ISO 13485 Consultants

Thank you Ronen
  Post Number #8  
Old 20th January 2018, 02:23 PM
xcanals_tecno-med.es's Avatar
xcanals_tecno-med.es

 
 
Total Posts: 90
Quid Pro Quo Re: Available ISO 13485 Consultants

Dear all

We are pleased to offer our services as consultants in order to prepare the adaptation to the EN ISO 13485:2016 and annex IX of the (EU) 2017/745 and (EU) 2017/746 MDR and IVDR medical devices regulation

Xavier Canals
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