Operon Strategist

Medical Device Consultant

Operon Strategist is turnkey project regulatory consultant provide services to the medical industry. We basically deal with the medical device, IVD's and primary packaging manufacturers. Our services include:

1. Manufacturing Plant Layout Design

2. Clean Room Design

3. Process validation

4. QMS and Certification like ISO 13485, ISO 15378, USFDA, CE marking, TGA, ANVISA, 21 CFR 820, 21 CFR 210, 21 CFR 211, etc.

5. Design and development for the combination product

6. Post-marketing support

Contact Details

Address Details

1500 Dahlia Ct Pflugerville

Phone:5127917633

E-mail: dm@operonstrategist.com E-mail: info@operonstrategist.com

Legal Entity: Other Founded: 2012 No Employs: Turnover:

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Opening Hours

Mo: 10:00 AM To 6:30 PM Tu: 10:00 AM To 6:30 PM We: 10:00 AM To 6:30 PM Th: 10:00 AM To 6:30 PM Fr: 10:00 AM To 6:30 PM Sa: 10:00 AM To 4:00 PM Su: 10:00 AM To 6:30 PM

Operon Strategist