SERVICE
Full Service for your Quality, Regulatory, Auditing and Compliance Needs
REGULATORY AND QUALITY ASSESSMENTS
Allow us to Assess your Regulatory and Quality
MDD93/42/EEC AND ISO 13485:2016 QUALITY AUDITING, AUDIT PREP, AND AUDIT SUPPORT, AUDIT DEFENSE
Allow us to Audit your Quality System, prepare you for your next external audit, and support you during your next external audit.
REGULATORY SUBMISSIONS AND REGISTRATIONS
EU CE Marking and Tech File/Design Dossier Creation and Maintenance. 510(k) Submissions to FDA, Pre-subs, Establishment Registrations, PMA Support, Notified Bodies, Device Listings, UDI, International Registrations (Latin America, Asia, Middle East)
CLINICAL EVALUATION REPORTS (CER)
MEDDEV 2.7/1 Rev 4
Clinical Literature Search
State of the Art Search
Regulatory Post Market Surveillance Review
GAP ANALYSIS
Regulatory Gap Analysis
CER Gap Analysis
MDSAP Gap Analysis
ISO 13485:2016 Gap Analysis
CE Mark Gap Analysis
MDR Gap Analysis
QUALIFICATION AND CERTIFICATES
RAPS Certified
MDSAP
CER MEDDEV 2.7.1 rev. 4
MDR
ISO 13485:2016 Auditor
University Degree Educated
Clients & Companies We've Worked With
LEADERSHIP TEAM
Jozef Kováč is Company Owner and Regulatory, Quality and Compliance Consultant for MDRC s.r.o.
Michal Pallo senior Quality and Regulatory Affairs Consultant
A performance and result-oriented leader who has broad experience in medical device industry. Has passion for challenging, improving processes and leading people. Very good in seeing the big picture, structured, systematic and good communicator.
Brings experience in the areas of regulatory affairs, quality management systems, compliance, and auditing. Works on activities associated with maintaining regulatory approval, compliance to ISO standards, FDA and European regulations among other international market authorizations of products.
Has wealth of expertise in non-active and substance-based medical devices, and drug-device combinations.
Competencies extend to general regulatory affairs and technical documentation preparation, conduct of thorough and EU MDR compliant clinical evaluations,
risk management activities in alignment with ISO 14971 and tailored implementation and maintenance of ISO 13485 and 21 CFR Part 820.
Being highly focused and disciplined, but always flexible, Michal excels in understanding and addressing the unique needs of our clients, particularly SMEs.
Never afraid to take on complex tasks that companies are either unsure how to tackle or prefer to outsource.
Jozef Kováč is Company Owner and Regulatory, Quality and Compliance Consultant for MDRC s.r.o.
A performance and result-oriented leader who has broad experience in medical device industry. Has passion for challenging, improving processes and leading people. Very good in seeing the big picture, structured, systematic and good communicator.
Brings experience in the areas of regulatory affairs, quality management systems, compliance, and auditing. Works on activities associated with maintaining regulatory approval, compliance to ISO standards, FDA and European regulations among other international market authorizations of products.
