Available FDA / Medical Device Consultants

[Marc]

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.

 

[DannyK]

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

 

[SilverHawk]

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]

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]

 

[amjadrana]

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]

 

[Marcelo]

Hello all

I offer consulting services in Brazil, Latin America and abroad.

Focus on regulatory affairs in general, risk management, standards, product development and other issues.

More info on the services page of my website: http://sqrconsulting.com/services

 

[Shoaibi]

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,

 

[Ronen E]

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,

Hi,

I'd be glad to assist. Please feel welcome to contact me directly: [email protected]

Cheers,
Ronen.

 

[Julie O]

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

 

[xcanals_tecno-med.es]

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