Mary Reeves

- Specialist responsible for regulatory affairs of the Wound Care division - FDA 21 CFR 820, EU MDD, EU MDR, ISO 13485, ISO 14971, ISO 10993, IEC 60601, and others - Design team RA representative for all Wound Care product development projects including 510(k) submissions and clinical investigations - EU MDR Transition support for Tech File and process updates - Supports new and maintains current registrations of Wound Care products

- Responsible for complaint documentation, investigation, and management for all product lines - Specializing in surgical and HCT/P orthobiologic products - Maintains high level of technical and clinical knowledge of products - Assesses severity and risk of complaint data for regulatory reporting and corrective actions - Prepares and submits regulatory reports to FDA and other global regulatory agencies - Analyzes complaint trending data for monthly reports and ongoing process improvements - Participates in PMS Activities including FMEAs, Supplier Risk Assessments, and annual PMS reviews - Core member of EU MDR Transition team responsible for PMS compliance - Updates procedures and internal documents using change control - Supports supplier/contract manufacturer, tissue bank, and internal audits - Works directly with Quality Control, Operations, Regulatory Affairs, Clinical Affairs, Sustaining Engineering, Product Development, Inventory Management, Customer Service, Sales and Marketing - FDA 21 CFR part 803 and 820, ISO 13485, GMP, GDP, EU MDR, MDSAP, and AATB standards - Diversity and Inclusion Council founding member

2018 CEO Award Winner

Responsible for the initial screening of patients to determine suitability for tissue donation, approaching families for consent for tissue donation, and completing of medical/social history on each potential donor. Acts as tissue services support to ensure proper processing of donors according to FDA and AATB standards.

Responsible for creating exceptional customer/member service experiences and for the safe and secure day-to-day operations

Accredited durable medical equipment facility specializing in post-mastectomy products and services.

Protein Purification and Analysis, Plasminogen Activation Inhibitor 1