- Do you have a brilliant idea for medical technology, but you need to know what requirements you have to meet?
- Are you working on the development of your medical device and preparing the device for certification?
- Or, you have already introduced a medical device on the market and now you are growing as a medical device manufacturer?
USE DevGoMed SUPPORT IN:
- Planning and implementing the medical technology development process, from concept through prototype to a final medical device on the market
- Organizing preclinical and clinical tests required for product certification, including biocompatibility assessment
- Quality management system implementation for manufacturing your medical device in accordance with EN-ISO 13485:2016 standard
- Technical documentation of your medical device development, necessary for CE mark product certification
THE ASSISTANCE OF MEDICAL TECHNOLOGIES DEVELOPMENT FROM IDEA
TO THE MARKET IS OUR PASSION!
MEDICAL PRODUCT IDEA
You have an innovative solution idea, you are writing a project and planning actions to obtain funding, you are not sure if you have planned everything well...
PRODUCT DEVELOPMENT QUIDING
You have received funding or have already funds for your product development, you have planned activities, but you need assistance to correctly guide the development of your medical device and successfully introduce it to the market...
PRODUCT DEVELOPMENT IN PROGRESS
You have already developed a prototype of your product, you have tested its functionality, and now you have a will to quickly introduce your medical device into the market...
JUST A STEP TO CE MARK
You confirmed new product properties in preclinical studies, but you still have the most challenging topics ahead of you - risk management report, clinical evaluation, technical documentation, medical device registration on the market, etc.
MEDICAL DEVICE CLASSIFICATION
CLINICAL EVALUATION CLINICAL INVESTIGATION
R&D PROJECTS MANAGMENT
CERTIFICATION AUDIT PREPARATION
MEDICAL DEVICE REGISTRATION
MEDICAL SOFTWARE DOCUMENTATION
IEC 62 304
MEDICAL DEVICE USABILITY
IEC 62 366
PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)
DevGoMed was created utilizing cooperation of experienced specialists in the field of design, research and implementation into clinical practice of innovative biomaterials and advanced medical devices, including implants.
A wide range of assistance in the medical technologies development, DevGoMed relies on experts’ many years experience in:
- planning and supervising the medical technology development
- risk management of a medical device along its life cycle
- managing R&D projects
- preclinical and clinical evaluation of medical devices
- implementing a quality management system for the production of a medical device in accordance with ISO 13485
- preparation of technical documentation of products to obtain the CE mark
- post-market surveillance of medical devices
The security of our Customer’s information is our top priority.
Our services are delivered to ensure that the implemented medical device is safe in accordance with the principle of maximizing user benefits.
We provide the highest quality level in our work, because its results represent quality of both: our Customer, and us.
Cooperation with DevGoMed supports high quality in creating, producing and delivering a medical device to the market.
We always operate effectively - we know that the implementation of our services must lead to our Customer achievement of specific business goals, and we take care of it at every stage of cooperation.