Available FDA / Medical Device Consultants

Marc

Hunkered Down for the Duration
Staff member
Admin
#1
If you are a consultant in FDA and Medical Devices 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 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.

NOTE: Your post count must exceed 150 posts to post in this thread.
 
Elsmar Forum Sponsor

DannyK

Trusted Information Resource
#2
Thanks for the opportunity.

Docusys Corporation, located in Montreal, Canada, specializes in ISO 9000, ISO 13485 and AS9100 consulting services.

I have assisted over 6 companies for registration to ISO 13485/88. Additionally I perform audits for the largest ISO 13485 registrar and am registered as an approved lead auditor to CMDCAS ( Health Canada requirements).

My fees are reasonable and I do not charge for telephone inquiries.



Danny
 
S

SilverHawk

#3
FDA/MDD Techncial Adviser - Malaysia

For those who wish to seek an experienced FDA/MDD Technical Adviser (Consultant) operating in ASEAN / Malaysian market, pls. contact Dr. K M Loi thru' email at [email protected] or log into www.kmloi.com

Ask for his CV.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#4
Statistical Consultant

Thanks for the chance to advertise...

I am a statistician with experience in medical device, pharmaceutical and biologics. I help companies with process validation, method validation, sampling plans and design of experiments for qualification and validation.

Steven Walfish
President
[email protected]
 
Last edited:

amjadrana

Involved - Posts
#5
Thanks, Marc for giving us the opportunity to assist others.

I will be happy to assist those in Ontario or specifically in Greater Toronto Area in the following:
• Quality Assurance and Regulatory Affairs for various industries – from chemical, textile, leather to medical devices.
• Establishing, implementing and maintaining ISO 13485 and ISO 9001.
• Leading companies to meet FDA, CE Mark, Health Canada and other regulatory requirements for medical device registration, approval and clearances.
• Creating systems to ensure quality assurance throughout the organization – from market requirements, product development and manufacturing to marketing and sales.
• Developing strategic business plans and key analyses of strengths and weaknesses.
• Developing training materials and implementing training for ISO 9001 and ISO 13485 at factory level.
• Carrying out regulatory registration and certification audits.
I can be reached at the following email address:

Amjad Rana
647-241-9786
[email protected]
 
S

Shoaibi

#7
Hi Marcelo Antunes and Hi to All,
I need to prepare technical files to submit our notified body for our Electro Surgical products.
Only Technical Documentation is required.

Thanks,
 
J

Julie O

#9
I'm a device regulatory consultant who has a lot of PMA experience, but is getting too old for PMAs. If you get in early, which I prefer to do, a good PMA can take 5-10 years, or even longer if you take it global. So now I'm interested in shorter term pre-market work, but not 510(k)s. This includes:

- Device classification and regulatory path
- FDA pre-submission meetings
- IDEs
- De novos (the "mini-PMA," perfect for me!)
- EU class III design dossiers
- EU clinical evaluation reports
 
Last edited by a moderator:

xcanals_tecno-med.es

Involved In Discussions
#10
Dear all

We are pleased to offer our services as consultants in order to prepare a:
- 510k for your medical device and obtain clearance from CDRH FDA
- Technical Documentation for (EU) 2017/745 and 2017/746 Regulations obtention of CE mark

Xavier Canals
 
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