Quality Management Systems

We help you set­ting up a Qual­i­ty Man­age­ment Sys­tem or adapt your sys­tem to the reg­u­la­to­ry require­ments. We have exten­sive expe­ri­ence in Qual­i­ty Sys­tems for Med­ical devices and Soft­ware devel­op­ment, both for small busi­ness­es and large med­ical companies.

VISAMED can pro­vide train­ing in Qual­i­ty Man­age­ment and Qual­i­ty Assur­ance matters.

Europe and Canada

  • Staff and man­age­ment train­ing on the require­ments of ISO 13485
  • Con­duct­ing inter­nal audit and design­ing effec­tive cor­rec­tive action plan
  • Assist­ing in the imple­men­ta­tion of cor­rec­tive audit plan
  • Imple­men­ta­tion of Risk Man­age­ment Pro­ce­dure in accor­dance with ISO 14971
  • Imple­men­ta­tion of Usabil­i­ty Files in accor­dance with EN 60601–1‑6 and EN 62366
  • Devel­op­ment of an effec­tive cor­rec­tive and pre­ven­tive action sys­tem (CAPA system)

USA (21 CFR § 820)

  • Staff and man­age­ment train­ing to the require­ments of qual­i­ty sys­tem reg­u­la­tions (QSR)
  • Devel­op­ment of an effec­tive Cor­rec­tive Actions and Pre­ven­tive Action sys­tems (CAPA system)
  • Imple­men­ta­tion of an effec­tive Haz­ard Analy­sis and Crit­i­cal Con­trol Points (HACCP) program
  • Process val­i­da­tion, includ­ing facil­i­ty mas­ter plans and assis­tance in the devel­op­ment of pro­ce­dures, pro­to­cols and reports, In process-con­trols and sam­pling, Fail­ure investigation

Supplier Assessments

  • Estab­lished a doc­u­ment­ed sup­pli­er eval­u­a­tion and sur­veil­lance system
  • Con­duct­ing audits of sup­pli­ers of prod­ucts and ser­vices as part of the FDA and Euro­pean qual­i­ty sys­tems requirements
  • Assist sup­pli­ers in meet­ing qual­i­ty requirements