Available ISO 13485 Consultants

Marc

Hunkered Down for the Duration
Staff member
Admin
#1
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.
 
Elsmar Forum Sponsor

DannyK

Trusted Information Resource
#2
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
 

Ronen E

Problem Solver
Staff member
Moderator
#3
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.
 

yodon

Staff member
Super Moderator
#4
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 [email protected].
 
Last edited by a moderator:

Ajit Basrur

Staff member
Admin
#5
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 !
 

xcanals_tecno-med.es

Involved In Discussions
#8
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
 

robert.beck

Involved In Discussions
#9
I'm a regulatory consultant in the USA. I am interested in working with someone familiar with regulations specific to Spain. what is your contact info?
 

somashekar

Staff member
Super Moderator
#10
Hi and Greetings.
I am an IRCA certified ISO 13485:2016 and ISO 9001:2015 lead auditor from BSI.
Based out of Bangalore city, India., I am available for any of the following assignments, either remote or on visit.
1. Gap analysis for the ISO 13485 and ISO 9001 implementation / Transition
2. Internal auditing (in line with ISO standards and FDA 21 CFR 820)
3. Awareness and Training about the new ISO 13485 / ISO 9001 / ISO 14001 / ISO 45001
4. Any other related specific project based consultation, including IMDR 2018 (Indian Medical Device Regulation) and other global regulatory requirements.
Please do contact me to discuss.
 
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