Osman Dursun Email & Phone Number
@consul-team.com
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Who is Osman Dursun? Overview
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Osman Dursun is listed as Owner, Medical Device RA and QA Expert at Medloft Consultancy Doo, a with 3 employees, based in Istanbul, Türkiye, Turkey. AeroLeads shows a work email signal at consul-team.com and a matched LinkedIn profile for Osman Dursun.
Osman Dursun previously worked as Owner, Medical Device RA & QA Expert at Medloft Consultancy Doo and Founder & General Manager at Consulteam Management Systems Consultancy Ltd.. Osman Dursun holds Bsc, Physics from Boğaziçi University.
Email format at Medloft Consultancy Doo
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About Osman Dursun
We help medical device manufacturers and start-ups to improve safety of medical devices. We work continuously with them throughout the complete product life cycle. Our main focus is design assurance and compliance with the applicable regulations and quality management systems such as; • EU MDR 2017/745• EU MDR 2017/746• US FDA 510 (K) Submission• ISO 13485 including MDSAP scheme • ISO 14971 Risk ManagementWith the latest revisions, the medical device regulations such as MDR, IVDR have been more complex than ever for medical device start-ups. All regulators within the developed countries are trying to increase the safety of medical devices within their market Therefore, patient safety and compliance to regulatory requirements constitute the basis of our consultancy project objectives. Our customer-focused team provides effective and fast services for each type of project and medical device.To help our customers in this complicated journey, we use our wide knowledge and experience to simplify the process. By doing this we always consider the balance between commercial needs and regulatory compliance. Our team with Notified Body experience is competent in risk management technical, regulatory, quality, and clinical requirements will provide you tailored solutions. This approach will speed up your certification process, whether you are a small start-up company or a competent medical devices manufacturer which aims to put new devices on the medical device market.Do not hesitate to contact us via askto@medloft.net or through https://medloft.net/contact-us/ We will analyse your needs and provide an effective, fast and reliable roadmap.
Listed skills include Medical Devices, Iso 13485, Fda, Ce Marking, and 26 others.
Osman Dursun's current company
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Osman Dursun work experience
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Owner, Medical Device Ra & Qa Expert
CurrentMedloft offers consulting services you need for your compliance with international medical device regulations and your quality management system applications.- Effective and on time consultancy and management for all QA&RA (Quality Assurance and Regulatory Affairs) processes- Pre-audit services to have a final review of your technical files or quality management system (Mock up Audits, Critical supplier/subcontractor audits, GAP Analysis for revised standards and regulations, internal audits)- In house training courses (These courses are designed to give practical knowledge through interesting workshops and meaningful learning tasks) Some of the main topics of our courses are; ISO 13485:2016, FDA 510 K Clearance, EU MDR /IVDR, MDSAP, Clinical Evaluation Reports and MEDDEV 2.7/1 Rev 4, Risk Management according to ISO 14971- Design Assurance services (Our services include; Design Verification and Validation, Human Factors/Usability Engineering Study, Risk Management, Design Quality Assurance, Design Quality Engineering
Founder & General Manager
CurrentConsulTeam is involved in providing consultancy services for management systems, particularly regarding engineering, R&D and manufacturing of medical devices (including IVD’s)- Quality Assurance and Regulatory Affairs consultancy services for medical device manufacturers (including IVD’s), particularly regarding engineering, R&D and manufacturing- Preparation of medical device technical files within various projects- Line optimization and process validation for medical device manufacturers- FDA 510 (K) file submission- Risk Management for medical devices (ISO 14971)
Emea Client Manager, (Er) Lead Auditor Medical Devices
External resource lead auditor and trainer for BSI Healthcare
Lead Auditor
- Registered Lead Auditor for ISO 13485 and 93/42/EEC directive- CE marking of many electronic and mechanical products including medical devices- QMS audits related with ISO 9001 quality management system (Main sectors of expertise include medical devices, electronics, mechanics, plastic injection, construction and textile)- Registered ISO 14001 environmental management system auditor
Quality Assurance Manager
- Line/process qualification and R&D of various civil and military projects in mechanics, electronics and electro-optics- Design and production engineer role and responsible from process validation and production engineering files transfer (the main projects electronic time fuse and ERYX guided missile manufacturing for the Turkish armed forces)- Leadership to the engineering team (Developed by this engineering team, "measuring system for the electronic time fuse project system" is still used by Turkish army for the acceptance tests)- Leading roles in the development of pre-paid electricity and water counter prototypes, magnetic shopping cards and web-kiosk applications- Technology transfer and project management- All quality assurance activities
Quality Assurance Engineer
- Quality assurance activities reporting- Test and design engineering roles (several mechanic, electronic and electro-optic projects such as infrared laser target pointers and monocular night vision goggles)
Osman Dursun education
Bsc, Physics
High School Diploma
Frequently asked questions about Osman Dursun
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What company does Osman Dursun work for?
Osman Dursun works for Medloft Consultancy Doo.
What is Osman Dursun's role at Medloft Consultancy Doo?
Osman Dursun is listed as Owner, Medical Device RA and QA Expert at Medloft Consultancy Doo.
What is Osman Dursun's email address?
AeroLeads has found 1 work email signal at @consul-team.com for Osman Dursun at Medloft Consultancy Doo.
Where is Osman Dursun based?
Osman Dursun is based in Istanbul, Türkiye, Turkey while working with Medloft Consultancy Doo.
What companies has Osman Dursun worked for?
Osman Dursun has worked for Medloft Consultancy Doo, Consulteam Management Systems Consultancy Ltd., Bsi, Sgs, and Transvaro Elektron Aletleri Sanayi Ve Ticaret A.Ş..
How can I contact Osman Dursun?
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What schools did Osman Dursun attend?
Osman Dursun holds Bsc, Physics from Boğaziçi University.
What skills is Osman Dursun known for?
Osman Dursun is listed with skills including Medical Devices, Iso 13485, Fda, Ce Marking, Regulatory Affairs, Quality Management, Quality System, and Business Strategy.
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