Evy Johnson Email & Phone Number

Started consulting firm to provide Quality Assurance Consulting services to blood establishments and diagnostic companies. Areas of expertise include:• Regulatory Affairs, FDA and EMEA submissions, • Medical Device and Blood Establishment registration, • Lookback procedure and blood component product specs• Writing documents including SOP formats, Technical product package inserts and manuals, manufacturing documents, Material Safety Data Sheets and marketing materials.• Perform audits of Blood Banks and Medical Device manufacturers and issue audit reports.

Direct all manufacturing operations, manage budgets, P&L responsibility for new business unit, oversee and direct research & development, quality assurance, facilities management including IT.Responsible for FDA registrations for medical device and blood establishment and FDA inspections and customer audits, writing audit responses. Analyze data and write and submit 510ks for company’s medical devices. Handle company’s Complaint and CAPA system, change control and employee training programs. Participated in CE mark training.