ProMedic is pleased to announce the hire of Nichole Leahy-Glass.

Nichole provides technical consulting services in Quality Management Systems. During her career, she has had several specific roles throughout the medical device life-cycle including Design Engineer, Quality Engineer, RA/QA Specialist, and Subject Matter Expert for Medical Device Start-ups and mid-sized companies. She has driven cohesion and compliance after acquisitions by merging disparate quality management systems into one Corporate Quality Management System through cross-functional team leadership. The industries she has served include Anaesthesia / Respiratory Care, Orthopaedics, Coronary / Peripheral Arterial Devices, Obstetrics / Gynaecology, Implantable, Neurological, Urological, Biopsy, Glucose / Blood monitoring, Surgical / Medical kits, Software as a Medical Device, General wellness and others. Nichole joined ProMedic in 2018 with a desire to continue supporting the Medical Device industry through assisting companies in achieving improved compliance and offering the benefit of her experience to build on the client’s foundations. She has a Bachelor’s Degree in Biomedical Engineering and is certified for ISO 13485:2016 auditing.

Work experience highlights

• Written and implemented Quality Management Systems for small and medium sized companies.
• Performed gap analyses between ISO 13485:2003 and ISO 13485:2016.
• Designed and developed disposable and implantable medical devices
• Planned and performed Design Verification and Validation
• Planned and performed Process Validation
• Lead Risk Management Teams utilizing FMEAs and Hazard Analyses
• Written Pre-submissions and 510(k)s
• Performed Post-Market Surveillance
• Remediated Design History Files and Technical Files
• Standards & Regulations: 21 CFR 820, ISO 13485, ISO14971, ISO 9001, CMDRs, MDD 93/42/EEC and numerous
applicable product specific standards.