Innovative products to improve life
Our goal is to collaborate with our clients in creating a better future. Within this market, we partner with companies seeking to take an innovative product from concept to production. This is why PEZY is actively involved in the development of medical devices, including hospital equipment, monitoring devices, and personal care products. Our focus lies in ensuring performance, safety, and convenience for both the patient and healthcare professional. If you are working in this sector and aiming to bring a new medical device to market, we are here to provide our expertise and support every step of the way.
User-centered design
Our developers are highly skilled at designing products that meet a wide range of requirements and needs, with a strong focus on the interests of the end users.
Regulatory compliance
Our technical specialists have extensive experience in developing products that must meet the strictest requirements derived from international safety standards. Additionally, at PEZY, there is a wealth of knowledge about European regulation 2017/745 (MDR) and compliance with harmonized standards such as ISO 13485 (quality management for medical devices) and ISO 14971 (risk management for medical devices), along with all related documentation.
Conformity assessment
PEZY can provide assistance with the classification of your medical device and with the conformity assessment process. For a Class 1 device, the manufacturer can perform the assessment themselves, but for higher classes, the assessment must be done by a Notified Body.
Your product on the market
With PEZY’s experience in producing and supplying wheelchairs through their venture O4 Wheelchairs, they have a deep understanding of the processes involved in bringing a medical device to market and ensuring compliance through post-market surveillance.
PEZY can take your medical device development to the next level and help you navigate the necessary steps for successful market entry and ongoing compliance.
