Project Experience

Serving the Biotechnology, Medical Device and In-Vitro Diagnostic, and Combination Product sectors, Ford & Associates offers 20 years of experience, implementing cost-effective and efficient quality management systems solutions and harmonized processes, while focusing on customer satisfaction and efficiency. Below is a representative list of projects.

2014

Supplier Compliance Audit
Class II Clinical Chemistry, Blood specimen collection device with additive

ISO 13485:2003 Second Party Audit (supplier audit) and technical documentation review

Warning Letter Response
Class I Spectacle Lenses

FDA Warning Letter response and QSR audit and report, Implementation of medical device reporting, product recall, CAPA and internal quality audit procedures, and MDR / CAPA training

2013

QMS Development
Class I Therapeutic Flotation Mattress and Wheelchair Accessories

QMS implementation and training in 21 CFR 820 and ISO 13485:2003 / Regulatory Affairs adviser

Regulatory Impact Assessment
Environmental Control Equipment Manufacturer for Healthcare Institutions

Regulatory and technical assessment, and report

QMS Audit
Class II Surgical Laser Systems

13485:2003 Quality Systems Audit

QMS Audit
Class II Intravascular Ultrasound Devices

ISO 13485:2003 / QSR internal quality audit and report

Due Diligence Technical and Compliance Audit
Class II Blood Glucose Monitoring Device / Class III Continuous Glucose Monitoring System

DHF Technical Review, Quality System Assessment, Clinical Data Review and due diligence report for business acquisition

Postmarket Performance Data Analysis – Combination Product
Class III Needleless Subcutaneous Drug Delivery System

Postmarket performance data analysis and presentation

QMS Audit – Combination Product
Class II Skin and Wound Cleanser

ISO 13485:2003 Certification Readiness Audit and Report

QMS Audit
Class II Balloon Sinuplasty devices

ISO 13485, 21 CFR 820, SOR 98-282, 93-42-EEC Internal Quality System Audits and Reports

2012

510(k) Submission
Class II Cardiovascular therapeutic device

510(k) for a hypothermia device, technical documentation review for DHF and Technical File

QMS Development
Class III Software as a Service (SaaS) device, glucose monitoring, CGM, insulin pump

QMS implementation and training in 21 CFR 820, ISO 13485, SOR 98/282 CMDR, MDD 93/42/EEC, and FISMA P.L. 107-347 / NIST SP 800-53

QMS Audit
Class II High power diode laser components and systems

QSR / 13485:2003 Quality Audit with gap analysis

QMS Audit – Combination Product
Class III Implantable ocular drug delivery device

Pre-Clinical Quality Management System audit with report, and DHF development

QMS Audit
Class II Pelvic Health Devices

Multiple ISO 13485:2003 Second Party Audits (supplier audit) and reports

Pre-IDE Submission Consultant – Combination Product
Class II Antimicrobial Drape / Combination Products

Implementation of design controls system for combination products, including products with software, DHF, and draft Pre-IDE submission for a new antimicrobial drape.

QMS and DHF Development – Combination Product
Class II Sodium Chloride Inhalation Solution

Quality System development and implementation for a combination drug / device, and development of the DHF

2011

QMS Audit
Class III implantable spinal cord stimulation system

QSR Audit and report

Due Diligence Assessment
Class II Cardiovascular therapeutic device

Technology Review, DHF Audit, 510(k) Audit, Due Diligence Technology Acquisition Assessment

QMS Development
Label Manufacturer

Development of an ISO 13485:2003 compliant quality management system for resale

Technical Transfer Support – Combination Product
Class III Implantable ocular drug delivery device

Technical Transfer assessment and report, Pre-Clinical technical review, LHR Review, PFMEA Development Support, Process Validation Support, QSR Audit and report

ERP Implementation Support
Class II Intravascular Ultrasound Devices / Cardiology Imaging Catheters

Internal Audits, Root Cause Investigation, Declaration of Conformity assessment, Product Certificate of Conformity Process Development, Nonconforming Materials System, Product Launch Support

QMS Audit
Class III Implantable Peripheral Nerve Stimulator with Software

ISO 13485:2003 pre-certification audit with gap analysis and report

2010

QMS Audit – Combination Product
Class III Inhalation Delivery System

ISO 13485:2003 Second Party Audit (supplier audit) and technical documentation review

Technical Transfer Audit – Combination Product
Class III Inhalation Delivery System

Technology Review, DHF Audit, Supplier Controls

QMS Development, PMA Support
Class III CAD Imaging Software

Quality Systems Development, Quality Audit, PMA preparation, Submission support, PAI Support, Process Validation

QMS Audit
Class III Nitinol stents and other devices

Annex II / CMDCAS Upgrade preparation and audit

Technical Transfer Audit
Class III Inhalation Delivery System

Review of DHF and IND documentation with report

Quality and Regulatory Compliance
Class II Hot/Cold Water Circulating Device with Software

510(K) preparation and submission, Claims audit, 93/42/EEC Annex V audit, Competitor analysis

QMS Audit
Contract Manufacturing Organization of Class II medical devices and components

ISO 13485:2003 Pre-Certification Audit to verify that modifications to the organization’s ISO9001:2000 quality management system conform to the requirements of ISO13485:2003

QMS Audit
Class II Surgical Laser Systems

13485:2003 Quality Systems Audit

QMS Audit
Class III Inhalation Delivery System

ISO 13485:2003 Second Party Audit (supplier audit) and technical documentation review