Lovett Consulting
Lovett Consulting, LLC is a full-service medical device quality assurance and regulatory compliance firm based in San Ramon, California. Since 1992, it has specialized in providing customized quality assurance, regulatory compliance, and related services to the medical device industry, including quality system strategies, audits, design control activities, compliance remediation, training, and regulatory submissions. Led by Linda Lovett, the company has over 25 years of experience supporting clients in various medical device sectors and is committed to advocating for quality and regulatory excellence.
Industries
Nr. of Employees
small (1-50)
Lovett Consulting
440 Bridle Court, San Ramon, CA 94582
Products
Design Control templates and forms
Downloadable design control procedure templates and associated forms (project initiation, product specification, phase review, traceability matrix).
Supplier management forms and questionnaires
Downloadable supplier quality system questionnaires, calibration service provider questionnaires, test laboratory questionnaires and supplier status approval forms.
QMS procedures and compliance package
Downloadable procedure packages covering topics such as complaint handling, CAPA, document control, risk management, manufacturing control, and regulatory inspection procedures.
Design Control templates and forms
Downloadable design control procedure templates and associated forms (project initiation, product specification, phase review, traceability matrix).
Supplier management forms and questionnaires
Downloadable supplier quality system questionnaires, calibration service provider questionnaires, test laboratory questionnaires and supplier status approval forms.
QMS procedures and compliance package
Downloadable procedure packages covering topics such as complaint handling, CAPA, document control, risk management, manufacturing control, and regulatory inspection procedures.
Services
Consulting to design and implement QMS tailored to organization size, including procedure development and metric integration.
Support for design control activities including customer requirements, product specifications, DHF assembly, and phase review facilitation.
Planning and execution support for engineering evaluation, design verification and validation activities and associated documentation.
Preparation support for regulatory filings and readiness programs for agency inspections and notified body audits.
Supplier program development, supplier questionnaires, supplier approval/change forms and supplier audits.
Remediation planning and execution for regulatory observations, notified body nonconformities and field actions.
Consulting to design and implement QMS tailored to organization size, including procedure development and metric integration.
Support for design control activities including customer requirements, product specifications, DHF assembly, and phase review facilitation.
Planning and execution support for engineering evaluation, design verification and validation activities and associated documentation.
Preparation support for regulatory filings and readiness programs for agency inspections and notified body audits.
Supplier program development, supplier questionnaires, supplier approval/change forms and supplier audits.
Remediation planning and execution for regulatory observations, notified body nonconformities and field actions.
Expertise Areas
- Medical device quality management system compliance
- Design control and design history file (DHF) development
- Design verification and validation (V&V)
- Regulatory submissions and inspection preparedness
Key Technologies
- Quality management systems (QMS)
- Design control processes and traceability matrices
- Risk management methodologies (ISO 14971)
- Regulatory submission frameworks (FDA/CE/Notified Body)
News & Updates
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