Consulting

 

Consulting has been in the recent years always the main activity of the founder Martin Hempel.To be always at the present status of the relevant standards, Martin Hempel is a member of several national and international standardisation committees.  International project management and global experience provide a base for superior challenges.

QA / RA
Quality management systems due to ISO 9000, 13485, JPAL, QSR
Review of Internal Processes, GAP Analysis, Pre-Audits
International approvals of medical devices
Interims Management

Medical devices
Project management in R&D, technical documentation,
specifications, selection of suppliers, material purchasing
International sales, start up, training

Main Projects since 2010

  • Cleaning and Sterilization (Validation, Guidelines, IFU's and e-learning Module)
  • MRI Safety (Validation)
  • Biocompatibility (Validation)
  • IEC 60601 3rd Edition
  • OEM-PLM Relationship, Review of technical file, Gap Analysis
  • Audit preparation and Pre-Audits (ISO and 21 CFR 820)


Other
Instructor “International Regulatory Affairs” of the “LGA Training and
Consulting” and the “TÜV Rheinland Group”
Member of the German standardisation committee of IEC 60601

When one of the above mentioned points is a bottleneck in your company we should talk with us.

Business Profile Martin Hempel