Birger Nispel has studied Biomedical Engineering in Aachen, Germany. In 1998 he founded his first company for distribution of medical devices. Between 2003 and 2009 he managed two private owned companies as well as he was service manager for a stock listed medical company with international operations up to 600 employees. In 2009 he founded AirMed PLUS GmbH, a medical device manufacturer of anti-bedsore systems and products for elderly care with a large European distribution network. Birger NISPEL is an international speaker and became a lead auditor for ISO 13485:2016. In 2018 he has been announced as “Company Embassador of Prefecture Fukushima, Japan” in 2020. His long term business experience is the basis for his succesful business coaching. NISPEL is a practitioner because he is working as an CEO of his own medical device company and knows about the mandatories to drive the medical device business successfully, including the money-eatin- gaps and hurdles, as well as about the opportunities when you consider intercultural condition.
Medical production companies need to run a QM System DIN ISO 13485:2016 which consist of a huge amount of records and documentation. Also, documentation of MDR requirements need to be described in written and recorded for running business after May 2021. Each processes in the company need to be written down and completely described from “a” to “z” . Each process have data-in-and-output-records which you need to archive. This costs an incredible invest in time to create all 24 chapters with processes and mandatory record for your next audit. This template tool-kit is YOUR already completely filled out QM Handbook, written in English language as a .docx file and rich in comments what is this particular sentence in this chapter used for and why. This complete template is your really incredible practical cost and time saving shortcut for fulfilling MDR and have succesfull business in medical field. This handbook and tool-kit is created by several lead auditors and QM trainers and has passed hundreds of audits already with success.
Explore free content for marketing, ISO 13485:2016, mind set, intercultural behaviour, etc.
Explore the list of hand-selected international partner companies. Browse the list and contact firstname.lastname@example.org to get personally introduced by Birger NISPEL with the management of the listed companies.