Team - adbccro

Our Leadership Team

Meet the visionary leaders driving smartData’s success. Our experienced and innovative leadership team is dedicated to guiding the company towards sustainable growth, technological advancement, and industry excellence. Discover the minds behind our strategic direction and continuous innovation.

andre-pic

Meet Andre Butler

Andre has 25 years' Experience in Clinical, Regulatory, Product Development, Quality Working in various environments and a wide variety of product introductions.

Past Responsibilities & Accomplishments:

Participated in more than 50 clinical studies
Managed a wide variety of Regulatory Submissions
Submitted Drug, Device and Combination Products
Managed various product mixes submissions, Class1, Class 2 and Class 3
Managed a variety of product types: IVD, external Electrical, Active Implantable
Constructed submissions for Registration, 510ks, IDEs, and PMAs
Managed Large Concurrent Submissions

Skill Sets:

Certified Clinical Research Professional
Certified Quality Auditor
Regulatory Association of Professionals Contributor
Technical File Expert
Labeling and IFU Expertise
Product Safety/ Serious Incident/ Field Safety Correction Action
Post Market Surveillance

Listed are just some of the pertinent skillsets. Andre’s CV is available on request.

More available on request

jose-pic

Meet Andre Butler

Andre has 25 years' Experience in Clinical, Regulatory, Product Development, Quality Working in various environments and a wide variety of product introductions.

Past Responsibilities & Accomplishments:

Participated in more than 50 clinical studies
Managed a wide variety of Regulatory Submissions
Submitted Drug, Device and Combination Products
Managed various product mixes submissions, Class1, Class 2 and Class 3
Managed a variety of product types: IVD, external Electrical, Active Implantable
Constructed submissions for Registration, 510ks, IDEs, and PMAs
Managed Large Concurrent Submissions

Skill Sets:

Certified Clinical Research Professional
Certified Quality Auditor
Regulatory Association of Professionals Contributor
Technical File Expert
Labeling and IFU Expertise
Product Safety/ Serious Incident/ Field Safety Correction Action
Post Market Surveillance

Listed are just some of the pertinent skillsets. Andre’s CV is available on request.

More available on request

dave-pic

Meet Andre Butler

Andre has 25 years' Experience in Clinical, Regulatory, Product Development, Quality Working in various environments and a wide variety of product introductions.

Past Responsibilities & Accomplishments:

Participated in more than 50 clinical studies
Managed a wide variety of Regulatory Submissions
Submitted Drug, Device and Combination Products
Managed various product mixes submissions, Class1, Class 2 and Class 3
Managed a variety of product types: IVD, external Electrical, Active Implantable
Constructed submissions for Registration, 510ks, IDEs, and PMAs
Managed Large Concurrent Submissions

Skill Sets:

Certified Clinical Research Professional
Certified Quality Auditor
Regulatory Association of Professionals Contributor
Technical File Expert
Labeling and IFU Expertise
Product Safety/ Serious Incident/ Field Safety Correction Action
Post Market Surveillance

Listed are just some of the pertinent skillsets. Andre’s CV is available on request.

More available on request

pedro-pic

Meet Andre Butler

Andre has 25 years' Experience in Clinical, Regulatory, Product Development, Quality Working in various environments and a wide variety of product introductions.

Past Responsibilities & Accomplishments:

Participated in more than 50 clinical studies
Managed a wide variety of Regulatory Submissions
Submitted Drug, Device and Combination Products
Managed various product mixes submissions, Class1, Class 2 and Class 3
Managed a variety of product types: IVD, external Electrical, Active Implantable
Constructed submissions for Registration, 510ks, IDEs, and PMAs
Managed Large Concurrent Submissions

Skill Sets:

Certified Clinical Research Professional
Certified Quality Auditor
Regulatory Association of Professionals Contributor
Technical File Expert
Labeling and IFU Expertise
Product Safety/ Serious Incident/ Field Safety Correction Action
Post Market Surveillance

Listed are just some of the pertinent skillsets. Andre’s CV is available on request.

More available on request

jeffery-pic

Meet Andre Butler

Andre has 25 years' Experience in Clinical, Regulatory, Product Development, Quality Working in various environments and a wide variety of product introductions.

Past Responsibilities & Accomplishments:

Participated in more than 50 clinical studies
Managed a wide variety of Regulatory Submissions
Submitted Drug, Device and Combination Products
Managed various product mixes submissions, Class1, Class 2 and Class 3
Managed a variety of product types: IVD, external Electrical, Active Implantable
Constructed submissions for Registration, 510ks, IDEs, and PMAs
Managed Large Concurrent Submissions

Skill Sets:

Certified Clinical Research Professional
Certified Quality Auditor
Regulatory Association of Professionals Contributor
Technical File Expert
Labeling and IFU Expertise
Product Safety/ Serious Incident/ Field Safety Correction Action
Post Market Surveillance

Listed are just some of the pertinent skillsets. Andre’s CV is available on request.

More available on request