Medical Device

Consulting Firm

There is no substitute for expertise in the medical device industry. Unfortunately, it isn’t always easy to find the talent, experience and other resources you need to keep up with all the advancements and developments that happen every day.

 

That is why so many choose GForce Life Sciences to be their medical device consulting firm. Whether we’re called upon to boost staffing levels, bring crucial knowledge on a project basis or identify executive leadership, we are here and ready to provide the medical technology consulting that will make the most difference.

 

Our extensive capabilities include virtually every aspect of the business, from medical device quality consulting to serving as an FDA consultant for medical device development. When companies put their faith in us, our ability to hand-pick the best consultants for their needs means they should have what they need to move up to the next level, including medical device regulatory consulting. Our experience in medical device management consulting includes executive search services to provide a steady hand on the wheel into the future.

What Sets Us Apart

 

No matter what we do for our clients, we always treat each one as an individual with unique needs and challenges. We never try to take a one-size-fits-all approach. We begin by taking a close look at your organization and what it will take to help you succeed.

 

With that information, we develop a plan that is tailored to you. We can combine our consulting, staff augmentation, subject matter expertise and executive search know-how in any way that best suits your requirements. This commitment to providing fully customized services is what sets us apart from virtually all other firms serving this sector.

 

If you’re ready to learn more about our services for the medical device industry or anything else we have to offer, reach out today to ask questions or get started.

  • Program & Project Planning

  • Resource Allocation & Management

  • Budget Establishment, Analysis & Tracking

  • Project Scope Definition

  • Coach, Mentor & Train others PMs

  • Functional Leaders & Team Members

  • Success Measures & Metrics (Dashboards)

  • Assessments

  • PMO & PPM

  • Help develop your DFM & AS

  • Environmental PFMEAS

  • Quality Management Systems

  • Deviation & CAPA Management

  • Process Design, Harmonization & Validation

  • QA/QC

  • Remediation Services

  • Unique Device Identification (UDI)

  • Design History File (DHF)

  • Device Master File (DMF) & Device Master Record (DMR)

  • Validation

  • Mock FDA Audits 

  • Sterilization

  • Computer Systems Validation

  • Clinical Trial

  • Product Development Process

  • Total Quality by Design

  • Process Development

  • Design Controls

  • Risk Management 

  • Quality Management System (QMS)

  • GMP

  • Baseline or Gap Assessment

  • Inspection Readiness

  • MDSAP Compliance Readiness Assessments

  • Supplier/Distributor

  • Contract Manufacturer

  • ISO 9001, 13485, 14971

  • 21 CFR Part 820

  • 21 CFR Part 11

  • Auditor Training

  • Operations & Manufacturing Strategy & Process Excellence

  • Technical Transfer

  • Innovation & Product Development

  • Sourcing & Procurement

  • Integrated Planning & Analytics, Logistics, Quality & Supplier Compliance 

  • Knowledge Capital

  • Implementation Accelerators

  • Analytics & Mobility

  • Control Towers

  • Contract Manufacturing 

  • Six Sigma

  • TPM

  • Supplier Audits & Remediation

  • FDA (483 Observations, Warning Letters, COnsent Decrees) Remediation

  • Submissions (Premarket Approval PMA, 510 (k), CE Mark & Compliance

  • Technical File & Design Dossier Preparation

  • Labeling, Packaging, Advertising & Promotional Materials

  • UDI

  • Global Regulatory Needs

  • Health Economics & Outcomes Research (HEOR)

  • Compliance

  • Medical Safety Development

  • Information Services

  • Communications

  • New MDR Requirements

  • Education

  • Program/Project Management

  • Quality System Gap Assessment

  • Product Gap Assessment

  • Creation/generation of complaint procedures, work instructions and templates to support a compliant MDR and/or IVDR system

  • Workshop facilitation, training and communication

  • Remediation: Post-Market Surveillance, Clinical Evaluation Reports, Product Technical Files and Design Dossiers