Services

Lovett Consulting, LLC is staffed by Industry experts who specialize in medical device and diagnostic devices (IVDD) who can help with quality system projects for compliance in the United States, European countries and Canada. Lovett Consulting, LLC can establish quality assurance strategies to build value in your company and align with the timing of your company’s regulatory milestones and objectives.

Examples:

• Full Quality System Establishment and Implementation for medical device and in vitro diagnostic devices

• Quality Strategy Development and Goal Alignment with Organizational Strategic Initiatives

• Acquisition and Integration Planning

• cGMP manufacturing facility qualifications – initial and facility moves

• Supplier qualification activities

• Management and Business Reviews, Quality System Oversight

Lovett Consulting, LLC specializes in early or mature stage businesses in the planning and implementation of compliant quality management systems that are customized for successful regulatory audits and inspections. Lovett Consulting, LLC performs gap assessments and develops written quality plans that align with company size, management structure, targeted markets, processes and products unique to the company. The implementation strategies are focused on regulatory and quality compliance to applicable regulations and standards with risk management integrated throughout.

Lovett Consulting, LLC is staffed by lead auditors qualified to perform audits to assess the adequacy and effectiveness of the company’s quality management system. Audits prepared and performed by Lovett Consulting, LLC are designed to assess the adequacy, effectiveness and the company’s ability to meet the requirements of applicable regulations, standards and internal quality management system procedures and to satisfy management responsibility. Audit activities can be requested to support your quality management system and/ or to assess the readiness for a regulatory audit or inspection.

Examples of Audits:

• Internal Audits

• External Audit Support

• Supplier Audits

Examples of Compliance Readiness Audits/ Assessments:

• PAI inspection (Pre-approval inspection)

• MDSAP (medical device single audit program)

• California Department of Public Health (FDB) medical device manufacturing license

• Routine FDA inspections (21 CFR 820)

• Notified Body Audits (ISO 13485, ISO 14971, IEC 60601)

Lovett Consulting, LLC is experienced in all phases of your product development project, whether you are looking for developing a design history file (DHF) for a new product from feasibility or concept through to market release, pre-commercial clinical use of a device or to support product design changes or iterations. Design Control activities are configured to meet your company’s needs and applicable regulatory requirements. Lovett Consulting, LLC can prepare test protocols and reports for design verification/ validation testing such as packaging, biocompatibility, sterilization, device testing, product software, usability engineering, risk management and others that would apply to the product.

Areas of Design Control Experience:

• Medical Devices: Orthopedic, Orthopedic Implants, Spinal, Vascular (Cardiovascular, Neurovascular), Electromechanical

• In Vitro Diagnostic Devices:Electromechanical Analyzers and Consoles, Controls, Reagents (Hematology, FOB, Transplant, Tissue Characterization)

Lovett Consulting, LLC can develop responses to regulatory observations and nonconformities, such as FDA’s 483s and Warning Letters or a Notified Body’s nonfulfillment of a requirement for the client to submit to regulatory agencies, develop corrective action plans, perform gap assessments, and provide assistance and support with implementation of remediation plans.

Lovett Consulting, LLC provides training for their clients that is customized to meet the client’s needs.

Areas of Training Interest:

• Quality System Regulation (QS-Reg, 21 CFR Part 820, ISO 13485)

• Risk Management (ISO 14971)

• Supplier Management Implementation

• Audit Preparation and Readiness

• Client Specific procedures

Lovett Consulting, LLC provides support for their clients for regulatory submissions.

• 510(k), PMA, Technical Files, Design Dossiers

Lovett Consulting, LLC provides expertise to support a client’s acquisition or integration activity. Activities may include performing due diligence audits, quality assurance procedure gap assessment and provide a written report identifying the gaps. Activities may also include developing an integration business or quality plan for implementation customized to fit the client’s strategies and goals.

Contact Lovett Consulting, LLC for general questions. We can help you meet your Regulatory and Quality staffing needs.

Examples of Other QA/RA Projects:

• Risk Management File Development and Maintenance

• Electromechanical Device Risk Management Files (IEC 60601)

• Corrective and Preventive Action (CAPA)

• Complaint Handling and Adverse Event Reporting

• Nonconformance Control Management

• Equipment Qualification Programs

• Supplier Management and Approved Supplier Listings (ASL)

• External Regulatory Inspection/ Audit Support

• Product Stability Monitoring

• Product Software QA Support