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Luca B. Email & Phone Number

Notified Body NB and Certification Body CBTL and Compliance Eng. and Quality Eng. and Manufacturing at Medical Devices Industry
Location: Ottawa, Ontario, Canada 3 work roles 3 schools
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✓ Verified August 2026 3 data sources Profile completeness 86%

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Current company
Medical Devices Industry
Role
Notified Body NB and Certification Body CBTL and Compliance Eng. and Quality Eng. and Manufacturing
Location
Ottawa, Ontario, Canada
Company size
283 employees

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Luca B. is listed as Notified Body NB and Certification Body CBTL and Compliance Eng. and Quality Eng. and Manufacturing at Medical Devices Industry, a with 283 employees, based in Ottawa, Ontario, Canada. AeroLeads shows a matched LinkedIn profile for Luca B..

Luca B. previously worked as Notified Body NB / Certification Body CBTL / Compliance Eng. / Quality Eng. / Manufacturing at Medical Devices Industry. Luca B. holds Bachelor Of Science, Quality Systems from Cambridge College.

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Medical Devices Industry

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About Luca B.

Product reviewer, Lead assessor QMS - Active Devices and Software (SiMD & SaMD): MDT 2001, MDT 2002, MDT 2007, MDT 2008, MDT 2010, MDT 2011, MDT 2001, MDS 1001, MDS 1006, MDS 1009, MDS 1010, MDA 0203, MDA 0204, MDA 0302, MDA 0305, MDA 0306, MDA 0307, MDA 0308, MDA 0309, MDA 0310, MDA 0311, MDA 0315, MDN 1103, MDN 1213, MDN 1204, MDN 1205, and MDN 1209.Lead and team member of third-party compliance audits to:• ISO 13485:2016• MDR 2017/745 (MDD 93/42/EEC)• MDSAP: Australian Therapeutic Goods Administration (TGA), Brazil's Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, Japan MHLW/PMDA, and the U.S. Food and Drug Administration (FDA)

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Medical Devices Industry
Medical Devices Industry
Notified Body NB and Certification Body CBTL and Compliance Eng. and Quality Eng. and Manufacturing
Pamplona, ES
Website
minutemaids.co.za
Employees
283
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3 roles

Luca B. work experience

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Role listed

Medical Devices Industry

Notified Body Nb And Certification Body Cbtl And Compliance Eng. And Quality Eng. And Manufacturing

Medical Devices Industry

Pamplona, Es

Notified Body Nb / Certification Body Cbtl / Compliance Eng. / Quality Eng. / Manufacturing

Medical Devices Industry

Ottawa, Ontario, Canada

Note: LinkedIn is a tool that I use to follow people, organizations, etc., that share relevant information akin to my professional field(s) of interest, and as a platform to stay in touch with dear (ex) colleagues. Hence, my shared personal information is quite limited. Product reviewer, Lead assessor QMS - Active Devices and Software (SiMD & SaMD): MDT 2001, MDT 2002, MDT 2007, MDT 2008, MDT 2010, MDT 2011, MDT 2001, MDS 1001, MDS 1006, MDS 1009, MDS 1010, MDA 0203, MDA 0204, MDA 0302, MDA 0305, MDA 0306, MDA 0307, MDA 0308, MDA 0309, MDA 0310, MDA 0311, MDA 0315, MDN 1103, MDN 1213, MDN 1204, MDN 1205, and MDN 1209.• Experienced Quality Auditor and Quality Engineer at Original Equipment Manufacturer (OEM) and Medical Device companies.• Experience working at Notified Bodies (NB), multiple codes related to plastics, metal, pharma, software, electronics.• Experience working at Certification Body and Nationally Recognized Testing Laboratories (CBTL and NRTL)• Certified Auditor of Quality Management Systems ISO 13485:2016/2003• Certified Auditor of Quality Management Systems ISO 9001:2015/2008• Reviewer of Risk Management File, per process standard ISO 14971 2019/2012/2007• Reviewer of Usability File, per IEC 62366 and IEC 60601-1-6• Reviewer IEC 62304, IEC 82304-1• Experience with GSPR relevant Medical Device Safety Standards.• Experience with Calibration and Preventive Maintenance.• Experience with personnel training.INTERNATIONAL WORK EXPERIENCE: Lived, worked, paid taxes in the following countries.Europe (Switzerland, Germany, Spain) and North-America (Canada and U.S.)LANGUAGES:English: Full professional working proficiency. Spanish: Full professional working proficiency.Italian: Limited working proficiency (Competence to review Technical Documentation and Reports).French: Limited working proficiency (Competence to review Technical Documentation and Reports).

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Colleagues at Medical Devices Industry

Other employees you can reach at minutemaids.co.za. View company contacts for 283 employees →

JD Jack Drake Jack Drake Colleague at Medical Devices IndustryAnderson, South Carolina, United States View → SW Sharon Womack Sharon Womack Colleague at Medical Devices IndustryNew York City Metropolitan Area, United States View → NK Nk Kumar Nk Kumar Colleague at Medical Devices IndustryDelhi, India View → JK Jnandev Kamath Jnandev Kamath Colleague at Medical Devices IndustryKarnataka, India View → AM Andrie Mallisa Andrie Mallisa Colleague at Medical Devices IndustryIndonesia View → MM Mahboube Meraji Mahboube Meraji Colleague at Medical Devices IndustryTehran, Tehran Province, Iran, Islamic Republic Of View → ML Martín Leon Martín Leon Colleague at Medical Devices IndustryPeru View → EB Ehab Barakat Ehab Barakat Colleague at Medical Devices IndustryUnited States View → SI Susmer, Inc. Susmer, Inc. Colleague at Medical Devices IndustryDenver Metropolitan Area, United States View → EB Erik Braziulis Erik Braziulis Colleague at Medical Devices IndustrySankt Gallen, St Gallen, Switzerland View →
3 education records

Luca B. education

Graduate Certificate, Medical Device Development

Uc Irvine
FAQ

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What company does Luca B. work for?

Luca B. works for Medical Devices Industry.

What is Luca B.'s role at Medical Devices Industry?

Luca B. is listed as Notified Body NB and Certification Body CBTL and Compliance Eng. and Quality Eng. and Manufacturing at Medical Devices Industry.

Where is Luca B. based?

Luca B. is based in Ottawa, Ontario, Canada while working with Medical Devices Industry.

What companies has Luca B. worked for?

Luca B. has worked for Medical Devices Industry.

Who are Luca B.'s colleagues at Medical Devices Industry?

Luca B.'s colleagues at Medical Devices Industry include Jack Drake, Sharon Womack, Nk Kumar, Jnandev Kamath, and Andrie Mallisa.

How can I contact Luca B.?

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What schools did Luca B. attend?

Luca B. holds Bachelor Of Science, Quality Systems from Cambridge College.

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