Integrity Expertise Results
Integrity Expertise Results  

 Medical Device Consultant
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BioVera provides consulting services to companies, investors, universities, and individuals that are researching, developing, and/or commercializing new biomaterials and orthopaedic devices.

BioVera’s services include FDA and Health Canada regulatory filings, FDA pre-submissions, 510(k) applications, planning and management of pre-clinical testing and reporting, technical file preparation in support of CE Mark, class 3 device strategy and FDA applications, clinical trial protocol development and strategy, and medical writing.
BioVera’s capability ranges from one-off advice on regulatory strategy, to 510(k) applications, to management of a company’s pre-clinical testing function and FDA regulatory affairs.

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Robert Poggie, PhD

Debbie Iampietro, BS, BA

Rita M Wadleigh, CQA

Milo Kral, PhD

Sam Nasser, MD, PhD
For more information about BioVera, contact Bob at:
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BioVera Phone & Fax: 514-901-0796 Mobile Phone: 514-349-7226  E-mail: