Stefano Adami

Stefano Adami Email and Phone Number

Competence Cluster Lead & Senior Consultant at confinis @ confinis
dudingen, fribourg, switzerland
Stefano Adami's Location
Zurich, Switzerland, Switzerland
Stefano Adami's Contact Details

Stefano Adami personal email

n/a
About Stefano Adami

Stefano Adami is a Competence Cluster Lead & Senior Consultant at confinis at confinis. He possess expertise in quality system, iso 13485, fda, validation, regulatory affairs and 10 more skills. Colleagues describe him as "very good student easy to work with and has great attention to detail"

Stefano Adami's Current Company Details
confinis

Confinis

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Competence Cluster Lead & Senior Consultant at confinis
dudingen, fribourg, switzerland
Website:
confinis.ch
Employees:
23
Stefano Adami Work Experience Details
  • Confinis
    Competence Cluster Lead &
    Confinis Feb 2019 - Present
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  • Confinis
    Senior Consultant
    Confinis Dec 2016 - Present
    Switzerland
    confinis is a consultancy specializing in providing advice and services to the medical device, pharmaceutical, biotech and diagnostic industries. confinis' core competences are in business practices – international regulatory affairs services, quality management (21 CFR Part 820 / 802 / 803 / 807, 21 CFR Part 4, Council Directive 93/42/EEC, ISO 13485, SOR/98-282), software development life-cycles (e.g. IEC 62304), product risk manage-ment (ISO 14971), usability engineering (IEC 62366), validation (computer system validation, process validation, GAMP5, 21 CFR Part 11 etc.), clinical evaluation, postmarket surveillance, vigilance, remediation activities, auditing, training, project management, strategic management, lifecycle management, innovation management, with particular expertise in new product development from idea through registration to commercialization. confinis also acts as an authorised representative for the EU for various clients.
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  • Sequana Medical Ag
    Regulatory Affairs Manager
    Sequana Medical Ag Jan 2016 - Dec 2016
    Zürich Area, Switzerland
    Sequana is a leading company in the body fluid management. The alfapump® system is an implantable active medical device with embedded software which communicates wireless with a smart charger to recharge batteries and to transfer data on physiological parameters which are then sent via GSM to Sequana for monitoring the device performances.Key responsibilities in Post Market Surveillance, Complaint Handling, Vigilance and Field Actions, Risk Management for ISO 14971, IEC 60601, ISO 62304, ISO 62366, International product registration. Supporting CE Certification, IDE studies and Design and Development for new and changed products, software/firmware, Auditing of suppliers. Create new SOPs work instructions and forms to drive global compliance .
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  • Zimmer
    Regulatory Affairs Senior Specialist
    Zimmer May 2014 - Dec 2015
    Winterthur Area, Switzerland
    Managing the introduction of a new global procedure on Risk Management across the organization, developing SOPs, guidance documents, keeping timelines and reporting progress to Corporate Headquarters. Key Team member for Design Control remediation activities giving regulatory input and providing guidance to quality improvements and new product development projects.General Regulatory tasks within CAPAs, maintenance of regulatory submissions, assess regulatory impact within Change Projects, manage International Regulatory Registrations.
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  • Limacorporate
    Regulatory Affairs Manager
    Limacorporate Nov 2007 - Apr 2014
    Managed a team up to 9 people with diverse focus on Regulatory and Pro-cess Validations, strict participation to the development of new products-processes, implementation and maintenance of Design dossiers for the Class III hip, knee and shoulder prosthesis, managing all the new registration in the non-EU Countries focusing on Japan, Australia, US, Canada, Brazil and China. Represent the company for the regulatory issues with other partner companies and suppliers. Managing the regulatory affairs of a new Trauma line of products after the acquisition of Hit Medica in 2008.Strict collaboration with the Quality Manager to draft quality procedures, SOPs to comply with ISO 13485 and QSR requirements. Managing the Complaints and Post Market Surveillance activities. In 2013 appointed as Process Validation Manager to follow up the introduction and validation of new coating technologies.
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  • Lima-Lto
    Regulatory Affairs Assistant
    Lima-Lto Oct 2004 - Oct 2007
    Drafting and maintenance of Technical files on orthopaedic devices according to MDD 93/42 EEC, Risk Analysis, preparation of the technical documentation for the registration of medical devices in Countries outside EEC (Registration in Japan, Mexico, Korea, China, Australia and maintenance of other registrations certificates).Packaging of orthopaedic systems: improvement of the packaging process and its validation, in collaboration with several European companies.Activities with regards to a research project founded by MIUR for the development of a novel knee orthopaedic system. Participation to an European research project (Sixth Framework Programme) for the development of micro-surgical instruments by means of a novel machine for direct micro-manufacturing with laser sintering of nanophased powders (www.manudirect.eu)
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  • The Medical House & Eurocut
    Scholarship “Progetto Leonardo”
    The Medical House & Eurocut Apr 2004 - Oct 2004
    Work experience performed in different departments with regards to the lifecycle of a novel needle free drug delivery system, from design (3D modelling, manufacturing of prototypes) to the Final quality control (Performance of several validation tests). Activities performed at the production department with regards to the manufacturing of surgical instruments for the orthopaedic field (CAM programming and machining of some products with CNC machines)

Stefano Adami Skills

Quality System Iso 13485 Fda Validation Regulatory Affairs Regulatory Submissions Medical Devices R&d Biomedical Engineering Surgical Instruments Sop Orthopedics Product Launch Quality Control Pharmaceutical Industry

Stefano Adami Education Details

Frequently Asked Questions about Stefano Adami

What company does Stefano Adami work for?

Stefano Adami works for Confinis

What is Stefano Adami's role at the current company?

Stefano Adami's current role is Competence Cluster Lead & Senior Consultant at confinis.

What is Stefano Adami's email address?

Stefano Adami's email address is ad****@****ahoo.it

What schools did Stefano Adami attend?

Stefano Adami attended Università Degli Studi Di Udine.

What skills is Stefano Adami known for?

Stefano Adami has skills like Quality System, Iso 13485, Fda, Validation, Regulatory Affairs, Regulatory Submissions, Medical Devices, R&d, Biomedical Engineering, Surgical Instruments, Sop, Orthopedics.

Who are Stefano Adami's colleagues?

Stefano Adami's colleagues are Urs Widmer, Barbara Jeroncic, Sara Conti, Guillaume Saint-Pierre, Beat U. Steffen, Rac, Fraps, Daniel M., Beatrice Longhin.

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