The EU, once a world leader in medical innovation, now faces tremendous challenges in implementing the new Medical Device Regulation (MDR). This framework, supposed to improve safety and transparency, has become a major hurdle for companies in the sector, holding back innovation and considerably increasing development costs.

The Swiss medical technology sector is diverse: around 1,400 companies are primarily active in the field of medical technology which encompasses almost 30 different medical specialties.

Destructive effects and frequency of « Laissez-faire Leadership » behavior M. IEMOLINI: Lic.in Clinical Psychology; Senior Partner at Rosapeak Advisors SA F.D

The internal audit is often a hot topic during the regular audit especially in small companies. The meaning of internal audits tends to be underestimated and neglected.

The internal audit is often a hot topic during the regular audit especially in small companies. The meaning of internal audits tends to be underestimated and neglected.

The implementation or the change from one QMS to another eQMS must be well planned and structured. It needs heavy endurance and support from the management and all users over the entire change period!

From the perspective of a lead auditor for ISO 13485 and 9001, I am exposed to many different quality management systems and company

The IVDR, which came into effect on May 26, 2022, introduced significant changes and more stringent regulations for in vitro diagnostic devices.

The world regularly changes. To remain competitive, your organization will sometimes need to change with it

Mergers and acquisitions involve lengthy and often secret negotiations between two companies. The larger of the two firms often

Consolidating acquisition: A consolidating acquisition occurs when an acquiring company buys another company to decrease competition.

Horizontal merger: This involves the merging of two entities in the same industry. Horizontal mergers often involve competitors