MEDICAL DEVICES
FROM IDEA TO CUSTOMER
Production, processes, training
Quality, ISO standards
Legislative support
Market entry and payment settings
Business models
We will guide you through the complex path of successful launch of a medical product on the market. We do not compromise on quality. We provide a comprehensive service from production support, process setup, staff training and motivation, ISO certification, legislative requirements for marketing, payment setup and we recommend functional business models. Whether you are a foreign manufacturer or distributor who wants to enter the Czech market or a local manufacturer who needs support in production, certification and sales - WE ARE HERE FOR YOU!
PRODUCTION
Optimization of production processes
MDR training including clinical studies
Post Marketing Surveillance
Vigilance system
QUALITY SYSTEM
Implementation of quality system ISO 9001 and ISO 13485
GAP analysis
MDSAP (Medical Device Single Audit Program)
ISO 13485 system implementation training and ISO 13485 internal auditor
Providing laboratory tests for medical devices of various classes
MARKET ENTRY
Preparation of technical documentation
Preparation for the award of the CE mark by a notified body
Registration at SUKL
Lawyer services
Ensuring the payment of ZP
Business models
MO CARE IS A MEMBER OF A PROFESSIONAL ORGANIZATION
A COMPREHENSIVE APPROACH TO THE MARKET ENTRY OF MEDICAL DEVICES
Ing. Jiří Monínec
CEO GM PROJECT / 26 years
Pharmaceutical and medical engineering
TEVA Opava (GALENA sp) / 20 years
Design of plants and equipment
Development, development and new investments / 20 years
Mgr. Alžběta Nejedlá
Process optimization / 7 years
SixSigma Lean Black Belt
HR management / 10 years
Managerial coaching and development / 10 years
Membership:
Czech Association for Psychotherapy
Ing. Jiří Pavlíček
CEO ASPIRONIX / 10 years
CEO Johnson & Johnson / 21 years
Membership:
IntMeda - Founder
CzechMed - Member of the Board of Directors
YPO - founding member
Ing. Tomáš Rys
Management of companies specialized in financing major companies and banks in the Czech Republic
Crisis management after the restructuring and transformation of major companies and banks in the Czech Republic
Exports of investment units to the Middle East and North Africa.
PharmDr. Renata Veselá
SQA Services
Lead Auditor ISO 13485, ISO 9001, GMP
NQA Global
Lead Auditor ISO 13485, ISO 9001
Teleflex
Quality Engineering Manager / Auditor
ISO 13485, ISO 9001, FDA 21 CFR 820, MDSAP, GMP, MDR, CMDR, PAL
Regulatory Affairs
Lean, Kaizen, VSM / VSD, Toyota Kata, Obeya, Shingo, Cpk, SPC, AQL, DOE
PharmDr. Renata Veselá
SQA Services
Lead Auditor ISO 13485, ISO 9001, GMP
NQA Global
Lead Auditor ISO 13485, ISO 9001
Teleflex
Quality Engineering Manager / Auditor
ISO 13485, ISO 9001, FDA 21 CFR 820, MDSAP, GMP, MDR, CMDR, PAL
Regulatory Affairs
Lean, Kaizen, VSM / VSD, Toyota Kata, Obeya, Shingo, Cpk, SPC, AQL, DOE
