About MedScan Kft.
"Your personal regulatory consultant."
I am an American living and working in Budapest, Hungary. Since 2003 I've been working in the field of medical device manufacture. During that time I've learned the following skills regarding medical device regulations and manufacture:
- Quality System
- Software Validation
- Auditing requirements (Internal and External)
- Essential Requirements
- Document Control
- Post-Market Surveillance
- Complaint and Non-Conforming Product Resolutions
- Applications for new registrations (specifically Canada, USA, EU, South Africa, Australia)
- Testing requirements
- Negotiation and Mediation Skills
Credentials
I have the following credentials to support my skills and past experience:
- Quality Systems Requirements and Industry Practice, offered by AAMI (Association for the Advancement of Medical Instrumentation) issued September 2004.
- Software Validation Requirements and Industry Practice, offered by AAMI June 2005.
- Member of RAPS (Regulatory Affairs Professional Society) since December 2008.
- Completed Canadian Medical Devices Requirements Online University Course through RAPS, March 2009
- Since 2003 continual on-the-job experience as Regulatory Manager
Contracting Options
I am currently committed to a number of clients but am available for new contracts. Contracting options include project basis or ongoing. For more information, please contact me,
Richard Lloyd, on richard@medscan.eu or telephone +36-20-559-1601.
Richard Lloyd
MedScan Kft.
Eotvos utca 25/a
1065 Budapest
Hungary