Important deadlines are coming from May 2024!
Medical device manufacturers and distributors have less than a year to comply with the new MDR regulatory environment.
If they want to stay on the market, those medical device manufacturers who have so far received a postponement and a grace period for their introduction for some professional reason will soon have to switch to production according to the requirements set by the MDR. From the end of May 2024, the quality management system of all companies that produce products that fall under the scope of the MDR must be MDR compatible.
For example, for so-called “legacy device” devices, the device can only remain on the market if the manufacturer (MF) or authorised representative (AP) has submitted a formal request to a notified body for conformity assessment under the MDR no later than 26 May 2024 and the parties have signed a written agreement no later than 26 September 2024.
In order to comply with the above requirements
FlexiTon Kft. and BioMedical Centrum Kft entered into cooperation
for the implementation of the “CTMed MDR support” software application – quality management IT solution.
In the collaboration, the medical technology scientific-professional
partner the BioMedical Centrum Kft.,
as long as IT and process management knowledge
provided by FlexiTon Kft.
COOPERATING PARTNERS:
BioMedical Centrum Kft.
BioMedical Centres Ltd. provides high-level professional support to domestic and foreign small and large companies (both manufacturers and distributors) in several scientific and professional fields.
BioMedical Centrum Ltd. was established in 2012 with the main objective of providing high level professional support in product registration tasks for domestic and foreign companies. Today, however, the range of services has been extended to include the preparation of literature, clinical summaries, expert opinions, scientific education and training, lectures, product marketing and consultancy.
BioMedical’s essential services for the changeover:
- ISO 13485 from scratch (full documentation, training, internal audit, management review support)
- Preparation or conversion of technical dossier to MDR requirements
- Special services: clinical evaluation (plan, analysis, report), biological evaluation according to standard (plan, analysis, report), PMS, PMCF plans, reports
- Preparation of PSUR
- Clinical studies (CRO services)
- Consultation, advice: training on obligations and tasks of manufacturers, distributors, importers, representatives
- Gap analysis: checking existing documentation, accurate and itemised identification of gaps, precise description of tasks required for MDR/IVDR compliance
The IT partner: FlexiTon Kft.
FlexiTon Ltd. provides data processing, geographic information technology and network design services for telecommunication service providers, municipalities, public institutions and enterprises, including a wide range of medical device manufacturers and distributors.
Our mission is to build on decades of professional experience to produce valuable knowledge from our customers’ processes and data.
Basic services for the changeover:
- Personalised software solutions
- Process analysis and design together with the customers
- Mapping of logistics and manufacturing processes
- Customization of forms, protocols, reports
- Migration of existing (historical) data – as required
- Software operation
- Implementation, installation
- System integration
- Initial assistance
- System support
CUSTOMIZED TO YOUR NEEDS!
Based on the combined knowledge of the two companies, together we will analyse the company’s operations and prepare our clients for the MDR transition – from the survey to the following services:
- Professional and IT assessment, consultation
- Introduction to the company’s business processes
- Test and trial run
- Training
- Initial assistance
- Support
- Change management
- Managing individual needs
Our professional and IT solutions ensure flexible and simple compliance put into practice: ‘quality management along the enterprise process’.
With the professional support of BioMedical Centrum Kft. FlexiTon Kft. has developed the CTMed MDR-supporting application, which is a customizable and extensible solution primarily based on the requirements of MDR regulation
-
-
- quality assurance,
- logistics and
- logistics and manufacturing areas;
- document management,
- reporting and production of required statistics.
-
CTMed provides a customised solution to support your quality assurance and quality management systems in line with the relevant ISO systems.
WIDESPREAD SUPPORT
Software support for quality assurance is extensive:
Software support for quality assurance is extensive, covering:
- process management,
- general document management,
- quality document management,
- management of quality assurance processes, quality assurance management, inspection management,
- deviation management (CAPA management),
- management of code and inventory systems,
- report and reporting,
- traceability
- and integration options.
Related services:
Consulting services related to the implementation of CTMed:
- Analysis of manufacturing and logistics processes,
- mapping of specific processes,
- system integration,
- Training,
- initial assistance,
- system support.
Data migration and implementation of additional specialised custom solutions are optional services if required and requested.
Benefits:
The benefits provided by the CTMed system include the implementation of a system that allows manufacturers and distributors to
- and manufacturers and distributors to manage their activities more efficiently,
- optimising quality assurance processes,
- and ensuring continuous documentation and data requirements.
We provide our customers with a user-friendly solution and complementary services to help them prepare for and comply with the MDR regulatory environment.
LET WE TALK ABOUT IT!
Let's start getting ready!
Because of the importance of the MDR requirements and the upcoming deadline, contact us as soon as possible and let’s start preparing together for 2024!
TOVÁBBI ALKALMAZÁSI TERÜLETEK
Naperőmű létesítési projektek menedzselése
Pályázattól az üzemeltetésig
Egyre nagyobb szerepe van a megújuló energiáknak, ezen belül is a támogatott napenergia termelésnek. A napelem szektor résztvevőinek egyszerre kell számos piaci és szabályozói követelménynek megfelelni, kiszolgálni az ügyfeleiket és hosszú távú stabilitást biztosítani a saját vállalatuknak.
Ebben segíthetünk Önöknek a CellTracker megoldásunkkal!
A megoldásunk naperőműves projektek levezénylését és nyomon követését segíti a földterület keresésétől kezdődően, úgy, hogy a CellTracker rendszert az Ön vállalkozásának sajátosságai alapján testre-szabjuk.
- Projekt fejlesztés főbb fázisai:
o A projekt kialakítása, megtervezése
o Lehetséges földterületek keresése, vizsgálata
o A DSO-hoz való csatlakozás előkészítése
o Szerződések kezelése
o Tervezés-engedélyeztetés ügyvitele
o A METÁR-pályázat kezelése
o Eladási döntések menedzselése - Naperőmű- létesítési projektmenedzsmentje
- Naperőmű- üzemeltetés feladat-feladatmenedzsmentje
Távközlés
Roll-out támogatás, világszerte több ügyfélnél
A CellTracker több mint egymillió bázisállomás kiépítésében és menedzselésében nyújt hatékony támogatást világszerte.
Funkciócsoportok (modulok) az alábbiak:
A szoftver moduljai koordinálják és menedzselik a roll-out folyamatot a site akvizíciótól a rádiós tervezésen át egészen az ügyfélszolgálati tevékenységig.
- Rádiós tervezés menedzsment
- Site akvizíció
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- Távközlés implementáció és integráció
- Hibajegy-kezelés
- Projektmenedzsment