Manager
Current
Nov 2024 - Present
AeroLeads people directory · profile
Ortzi Olasolo Email & Phone Number
Medical Device Consultant at Beyond Conception en Beyond Conception GmbH
at
Beyond Conception GmbH
1 work email found
@upm.es
LinkedIn matched
✓ Verified July 2026
4 data sources
Profile completeness 100%
Current company
Role
Medical Device Consultant at Beyond Conception en Beyond Conception GmbH
Location
Basel, Switzerland
Company size
Who is Ortzi Olasolo? Overview
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Quick answer
Ortzi Olasolo is listed as Medical Device Consultant at Beyond Conception en Beyond Conception GmbH at Beyond Conception GmbH, a with 9 employees, based in Basel, Switzerland. AeroLeads shows a work email signal at upm.es and a matched LinkedIn profile for Ortzi Olasolo.
Ortzi Olasolo previously worked as Manager at Beyond Conception Gmbh and Medical Device Consultant at Beyond Conception at Beyond Conception Gmbh. Ortzi Olasolo holds Master Of Science (Msc) In Biomedical Engineering, Ingeniería Biomédica/Médica, 9/10 from Universidad De Navarra.
Company email context
Email format at Beyond Conception GmbH
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oolasolo@upm.es
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AeroLeads found 1 current-domain work email signal for Ortzi Olasolo. Compare company email patterns before reaching out.
Profile bio
About Ortzi Olasolo
I am a regulatory expert with a solid background in biomedical engineering and proven track record in product, process development and validation of drug device combination products and medical devices. I am currently located in Basel, Switzerland, where I work among others for Novartis. I have experience with global submissions, agency interactions and authoring dossiers (e.g. Notified Body submissions) and possess a comprehensive understanding of Quality Management Systems, Design Controls, Clinical Evaluations, Risk Management and Human Factors Engineering based on the following regulations, guidances and standards:• Medical Device Regulation 2017/745.• FDA QSR.• ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes.• ISO 14971 - Medical devices - Application of risk management to medical devices.• ISO 10993 - Biological Evaluation.• Food and Drug Administration (FDA) - Design Control Guidance for Medical Devices Manufacturers.• IEC 62366-1 - Human Factors and Usability EngineeringI am passionate about Getting Things Done (GTD) methodologies, applying and teaching them with excellent results.
Listed skills include Matlab, Microsoft Office, Latex, Java, and 11 others.
Current workplace
Ortzi Olasolo's current company
Company context helps verify the profile and gives searchers a useful next step.
Beyond Conception Gmbh
3 roles
Ortzi Olasolo work experience
A career timeline built from the work history available for this profile.
Medical Device Consultant At Beyond Conception
CurrentProvided regulatory support for several international clients, including reply to requests from Notified Bodies related to Article 117 and medical device conformity assessments.Developed end-to-end a fully customized ISO 13485 compliant QMS including generation and review of SOPs.Generation of Annex I deliverables matrix and checklists.Review and gap assessment on documentation to be submitted for obtaining Notified Body Opinions (NBOp) for Combination Products. Developed Clinical Evaluation Plans and Reports. Developed and gave trainings and workshops on several topics related to Medical Devices/Combination Products and QMS.
Feb 2021 - Present
Product Developer/Quality Analyst
Kiro Grifols
Handled critical device certifications (UL, EMC and others)Handled non-conformities, incidences, and CAPAs (Corrective and Preventive Actions)Product Requirement and Product Design Specification definition Verification and Validation of specifications and requirements (Including protocol drafting, executing and reporting) Development of technical documentation, work instructions, Standard Operating Procedures (SOPs) and others. Development and maintenance of Risk Analysis Documentation (FMEAs)
Jun 2017 - Feb 2021
Team & coworkers
Colleagues at Beyond Conception GmbH
Other employees you can reach at beyond-conception.com. View company contacts for 9 employees →
3 education records
Ortzi Olasolo education
Master Of Science (Msc) In Biomedical Engineering, Ingeniería Biomédica/Médica, 9/10
Bachelor'S Degree In Biomedical Engineering, Bioingeniería E Ingeniería Biomédica, 8/10
International Baccalaureate - Usandizaga Peñaflorida Amara, Science
FAQ
Frequently asked questions about Ortzi Olasolo
Quick answers generated from the profile data available on this page.
What company does Ortzi Olasolo work for?
Ortzi Olasolo works for Beyond Conception GmbH.
What is Ortzi Olasolo's role at Beyond Conception GmbH?
Ortzi Olasolo is listed as Medical Device Consultant at Beyond Conception en Beyond Conception GmbH at Beyond Conception GmbH.
What is Ortzi Olasolo's email address?
AeroLeads has found 1 work email signal at @upm.es for Ortzi Olasolo at Beyond Conception GmbH.
Where is Ortzi Olasolo based?
Ortzi Olasolo is based in Basel, Switzerland while working with Beyond Conception GmbH.
What companies has Ortzi Olasolo worked for?
Ortzi Olasolo has worked for Beyond Conception Gmbh and Kiro Grifols.
Who are Ortzi Olasolo's colleagues at Beyond Conception GmbH?
Ortzi Olasolo's colleagues at Beyond Conception GmbH include Tonya Susott, Emma Díaz González, and Thierry Rimlinger.
How can I contact Ortzi Olasolo?
You can use AeroLeads to view verified contact signals for Ortzi Olasolo at Beyond Conception GmbH, including work email, phone, and LinkedIn data when available.
What schools did Ortzi Olasolo attend?
Ortzi Olasolo holds Master Of Science (Msc) In Biomedical Engineering, Ingeniería Biomédica/Médica, 9/10 from Universidad De Navarra.
What skills is Ortzi Olasolo known for?
Ortzi Olasolo is listed with skills including Matlab, Microsoft Office, Latex, Java, Javascript, Sql, Node.Js, and Labview.
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