MDR Compliance

 Challenge: A long-standing client, a small company specializing in innovative minimally invasive endosurgical devices, needed to maintain their existing CE Mark while updating their QMS to comply with the new Medical Device Regulation (MDR). Facing limited resources to implement the new regulations and update their documentation for an MDR submission, they trusted AlvaMed’s proven track […]

Large Company QMS Harmonization

LARGE COMPANY QMS HARMONIZATION CASE STUDY CHALLENGE:One of the world’s largest life science companies was experiencing a significant increase in scrutiny from the FDA. At a time when the FDA’s increased expectations of QMS harmonization within large integrated life science companies had increased, multiple audits highlighted the need for harmonization across the company’s groups. The […]

MANAGING CHANGES AND MAINTAINING COMPLIANCE

Under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), devices need to meet the applicable “harmonized standards” to demonstrate conformity with the essential requirements. If a harmonized standard referenced in the technical documentation (including the DHF) is updated, manufacturers are expected to assess the impact and incorporate any necessary changes […]