We provide consulting services related to the development process of a medical devices - from the concept stage, through the design and testing of the prototype, clinical evaluation to implementation on the medical device market and post-marketing surveillance.
We are experts in:
• Planning and implementing the development process of medical devices for certification (project planning, design, preclinical and clinical tests, preparation for the certification audit)
• Quality management system implementation for manufacturing your medical device in accordance with EN-ISO 13485:2016 standard
• Risk management process of medical devices
• Technical documentation of your medical device development, necessary for CE mark product certification
• Organizing preclinical and clinical investigation required for product certification, including biocompatibility evaluation.
We perform personalized training, support in the process of funding application, manage R&D projects in the MED-TECH industry.
We offer outsourcing of services: ISO 13485 QMS representative, person responsible for regulatory compliance (PRRC), consultant in the area of compliance with MDR requirements.
Please do not hesitate to contact us!
Company Details
- Employees
- 6
- Founded
- -
- Address
- Słowackiego 2a, Lok. 1.03,poland
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- http://www.devgomed.com
- Keywords
- wyroby medyczne, certyfikacja, analiza ryzyka, zarządzanie projektami, MDR, ISO 13485, MDSAP, IVDR, ocena kliniczna.
- HQ
- Zabrze, śląskie
Devgomed Questions
Devgomed's website is http://www.devgomed.com
Devgomed's LinkedIn profile is https://pl.linkedin.com/company/devgomed
Devgomed has
6 employees.
View email and phone details for 6
employees at Devgomed.
Devgomed's industry is
Business Consulting and Services
Devgomed's top competitors are
Przedsiębiorstwo Konsultingowe Agm,
Revolve Healthcare,
Hetalox,
Vimex Endoscopy,
Prometheus Medtech.ai,
Medmeetstech,
Coal Mining Museum In Zabrze,
Revolve Healthcare,
Tuv Nord Polska,
Medtech Meetup Poland.
Devgomed's categories are Business Consulting and Services
Devgomed's founding year is 2020
