Development and production of substance-based medical devices
Fairpharm GmbH was founded in the nineties and since then has been specializing in the development and production of substance-based medical devices. The company is located in the idyllic town of Bad Heilbrunn, south of Munich and belongs to the Johannes Burges family foundation together with companies such as Bad Heilbrunner Naturheilmittel GmbH & Co. KG, HERMES Arzneimittel GmbH und HERMES PHARMA GmbH Teil der Johannes Burges Familienstiftung.
Fairpharm GmbH is a valued and important partner for industrial customers in the pharmaceutical and healthcare sector worldwide when it comes to medical devices. Apart from their development and production, we also provide our customers with our entire legal expertise. This includes the creation of the necessary technical documentation, the coordination of all action needed for the certification and last but not least placing the final product on the market.
Our medical devices contain ingredients such as macrogol and simethicone and are brought to market as orally disintegrating granules (oral powders or oral granules) as well as instant drinks (granules for oral solution or powders for oral solution).
Each Fairpharm product is manufactured in state-of-the-art facilities and is thoroughly examined and assessed before declaring its conformity. Fairpharm‘s production and assessment as well as quality management at all times meet the current legal requirements of the standard ISO 13485 in connection with the requirements of the MDD (93/42/EEC) and - in addition - of the recognized guidelines for the manufacture of pharmaceutical products (EU-GMP). We have carefully planned the switch to the new requirements of the MDR (EU) 2017/745 and are implementing them in our QM system within the prescribed deadlines.
The adherence to the stringent quality management requirements is verified at least once a year by independent authorities such as TÜV Rheinland in announced or unannounced inspections. Besides this, selected partners from the pharmaceutical industry who take over the distribution of our products carry out additional inspections. Thanks to these measures, we can guarantee the constant very high quality of our products.
Our medical devices contain ingredients such as macrogol and simethicone and are brought to market as orally disintegrating granules (oral powders or oral granules) as well as instant drinks (granules for oral solution or powders for oral solution).
Each Fairpharm product is manufactured in state-of-the-art facilities and is thoroughly examined and assessed before declaring its conformity. Fairpharm‘s production and assessment as well as quality management at all times meet the current legal requirements of the standard ISO 13485 in connection with the requirements of the MDD (93/42/EEC) and - in addition - of the recognized guidelines for the manufacture of pharmaceutical products (EU-GMP). We have carefully planned the switch to the new requirements of the MDR (EU) 2017/745 and are implementing them in our QM system within the prescribed deadlines.
The adherence to the stringent quality management requirements is verified at least once a year by independent authorities such as TÜV Rheinland in announced or unannounced inspections. Besides this, selected partners from the pharmaceutical industry who take over the distribution of our products carry out additional inspections. Thanks to these measures, we can guarantee the constant very high quality of our products.
Certificates and approvals
of the Fairpharm quality management system
QM system DIN EN ISO 13485:2016 (TÜV-Rheinland), valid until 21 October, 2026 View certificate
QS certificate in accordance with guideline 93/42/EWG, annex II excluding section 4 (TÜV-Rheinland), valid until 26 May, 2024 View certificate