Medical Devices The FDA’s Quality Management System Regulation (QMSR): An Introduction and Compliance Guide FDA Auditing How to Prepare for the QMSR: A 7-Step Strategy Process Tips for Writing an Effective FDA 483 Response 510K PROCESS FDA 510(k) Submission: The Anatomy of a Successful Premarket Notification Quality Systems Mock BIMO Inspections: A Basic Guide to Readiness in 2024 FDA Compliance Inside FDA's Proposed Rule to Regulate Laboratory Developed Tests (LDTs) GCP Clinical Investigator Site Audits: A Guide and Checklist FDA Auditing Supplier Audits in the FDA-Regulated Industries: A Guide for Quality Leaders GxP 21 CFR 211.22(d): An Introduction and Compliance Guide Validation Computer System Validation (CSV) in the FDA-Regulated Industries MDSAP MDSAP Audits: A Starter Guide for Device Manufacturers Medical Devices PMA vs. 510(k): Everything You Need to Know (2024) Regulations 5 Items to Stock in Your FDA Inspection War Room ANDA Abbreviated New Drug Applications (ANDA) Explained: A Quick-Guide FDA's 505(b)(2) Explained: A Guide to New Drug Applications Process A Basic Guide to Mock FDA Inspections/Audits Quality Systems Deviation Management in the FDA-Regulated Industries: Basics and Best Practices CAPA Corrective and Preventive Action (CAPA): The Definitive Guide [2024] MDSAP MDSAP Preparation in 2024: A Complete Guide for Medical Device Firms A Quick Introduction to Our Functional Service Program (FSP) 510K PROCESS FDA 510(k) Explained: A Basic Guide to Premarket Notification MDSAP BIMO Inspections: A Guide to Basics and Best Practices FDA Inspections FDA Warning Letter & Inspection Observation Trends [Updated 2023] FDA Inspections 7 New FDA Inspection-Related Policies in the Food and Drug Omnibus Reform Act Quality Systems A Step-by-Step Guide to Quality System Remediation GxP 21 CFR 211.192: An Introduction and Compliance Guide Process Medical Device Complaint Handling: 8 Common Problems (and How to Solve Them) FDA Warning Letters 'CGMP Consultant Recommended' - A Guide to FDA Warning Letter Response Staff Resourcing The Life Science Hiring Manager's Guide to Staff Augmentation Process A 5-Step Guide to Qualifying FDA-Regulated Suppliers Validation A Basic Guide to Process Validation in the Pharmaceutical Industry Medical Devices MDR vs. MDD: 13 Key Changes GxP A Basic Guide to Good Manufacturing Practice (GMP) Audits Staff Resourcing How to Find the Right Pharmaceutical Recruitment Agency Good Manufacturing Processes The Differences Between GCP, GLP and GMP Audits Process A Basic Guide to Writing Effective Standard Operating Procedures (SOPs) Pharmacovigilance Good Pharmacovigilance Practices (GVP): A Quick-Guide Quality Systems 21 CFR 211.25 & Quality Personnel: A Guide to GMP Compliance Compliance Consulting The Biologics License Application (BLA) Process Explained FDA Warning Letters How to Prepare for an FDA Inspection: 6 Quick Tips Process GMP vs. GLP in Laboratory Testing & Validation FDA Inspections Pre-Approval Inspection (PAI): An Expert Guide to Preparation Medical Devices CAPA Compliance: 4 Problems That Can Threaten Your Process 503B 503A vs. 503B: A Quick-Guide to Compounding Pharmacy Designations & Regulations Data Integrity Data Integrity Remediation: A Quick-Guide to Investigating & Resolving Root Cause Staff Resourcing Quality System Resource Planning: A Guide for the Life Sciences Staff Resourcing Partnering With a Life Science Resourcing Firm: 3 Quick Tips Quality Systems 6 Key Takeaways from the CDER’s State of Pharmaceutical Quality Report FY2020 Validation Hiring the Right Validation Consultant: 7 Key Considerations FDA Warning Letters 5 Key Questions to Ask After Receiving an FDA Warning Letter Quality Systems Compounding Pharmacies and CGMP: A Primer FDA Inspections New FDA Report Presents Potential Scenarios for Returning to Normal Inspections Life Science Consulting Life Science Consulting Contracts: 5 Things Companies Should Look For Before Engaging a Firm FDA Inspections How to Prepare for Remote FDA's Remote Interactive Evaluations Process An Informed Guide to Human Error in CAPA In the News Key Takeaways from FDA's Guidance for Resuming Drug and Biologic Manufacturing Operations During COVID-19 FDA Inspections 7 Key Takeaways from FDA's Pandemic Inspections FAQ Guidance CGMP Remote Auditing Best Practices & Checklist for Regulatory Compliance Staff Resourcing 5 Benefits of Workforce Insourcing: A Guide for the Life Sciences FDA Inspections What Happens During an FDA Inspection? News Coronavirus Disrupting Supplier Audits in FDA-Regulated Manufacturing: Get Local Resources Now FDA Compliance A Quick Guide to FDA's Expectations for Supplier Quality Validation What Makes For a Good Validation Master Plan? In the News Life Science Quality Assurance in 2020: 5 Key Trends GxP Auditing Contract Manufacturers: 10 Questions for Improving CGMP Assessment Data Integrity Conducting Data Integrity Audits: A Quick Guide ISO:13485:2016 Preparing for an ISO 13485:2016 Audit: A Starter Guide Quality Systems Pharmaceutical Quality Assurance: FDA's Quality Unit Expectations News A Versatile Solution to Consulting and Staffing: An Update from The FDA Group Pharmaceuticals Pharmaceutical Microbial Testing: Are Your Methods Established & Suitable? Process 6 Ingredients of an Effective Internal Audit Program FDA Warning Letters FDA Continues to Cite OTC Drugmakers for CGMP Violations FDA Compliance A Guide to FDA's New Inspection Protocol Project (NIPP) for Sterile Manufacturing Sites In the News FDA’s Crackdown on OTC Manufacturers: A Guide to CGMP Compliance Medical Devices FDA Medical Device Inspections in 2019: Inside 2 Recent Draft Guidances Pharmaceuticals A Guide to FDA's 'Risk-Based' Site Selection Model for CGMP Surveillance Inspections Good Manufacturing Processes FDA Increases 'Risk-Based' Drug Manufacturing Inspections & Strengthens Genotoxic Impurity Testing Cybersecurity GxP Electronic Record Metadata: Mitigating Regulatory Risks Staff Resourcing 5 Steps to Creating an Effective Life Science Validation Team Medical Devices A Quick Guide to MDSAP's New Nonconformity Grading System Medical Devices Inside FDA's Final Guidance on Device Manufacturing Site Changes Quality Systems Medical Device Document Control: 4 Common Issues to Avoid Medical Devices What The FDA Expects From Your CAPA Process Medical Devices FDA to Add Cybersecurity to RTA Checklists & Other Criteria For Premarket Review 503B FDA Announces Increased Risk-Based Oversight for 503A & 503B Compounding Facilities Medical Devices The Problem with 8D for CAPA Under FDA and ISO Regulations FDA regulatory consultants 4 Ways Regulatory Compliance & QA Consultants Offer Unique Value & Cost-Effectiveness CAPA How to Determine When CAPA is Appropriate In the News EUDAMED Nomenclature Requirements: Inside the First EU MDR and IVDR Guidance Medical Devices EU-MDR Compliance & Transition: A Strategy for Implementation Medical Devices The First Step in Transitioning to EU-MDR Compliance Medical Devices A Quick Guide to Clinical Evaluation Under EU-MDR In the News FDA Final Rule: Foreign Medical Device Trials Must Conform to GCP In the News New Report Analyzes Recent Spike in CDER Warning Letters Medical Devices Is Medical Device Risk Analysis Required by the FDA? Medical Devices [Free Webinar] The Complete Guide to EU-MDR Transition FDA Inspections Foreign FDA Inspections: A Guide to FDA's Pre-Inspection Procedures Compounding Pharmacies Preparing for FDA's Proposed CGMP Regulations for Compounding Pharmacies In the News FDA Warning Letter & Enforcement Trends of 2017: A Year in Review ANDA Preventing FDA Refuse-to-File Decisions for NDAs, ANDAs, and BLAs: A Quick Guide Quality Systems Assessing the Applicability and Necessity of CGMP to Drug Compounding Good Manufacturing Processes [Webinar Snippet] Key QMS Components for Compounding Pharmacy CGMP Compliance Data Integrity 4 Ways Data Integrity is Being Improved in Clinical Research In the News 5 Items on FDA's 2018 Regulatory Agenda Quality Systems Quality System Centralization vs. Decentralization: The Pros & Cons In the News FDA Makes Changes to Priority ANDA Draft Guidance Risk Management 3 Key Areas to Assess When Integrating an Incoming Quality System 503B [Free Webinar] The Importance of CGMP to the Safety of Compounded Drugs In the News FDA Will Recognize GMP Inspections from 8 EU Countries Medical Devices [Free White Paper] Harmonizing Disparate Quality Systems Medical Devices 3 Clarifications Made in FDA's 510(k) Submission Final Guidances In the News HHS Office of Human Research Protection Delays Implementation Deadline for Changes in Common Rule Medical Devices Canada Still On-Track for 2019 MDSAP Deadline Medical Devices Combination Product Compliance: 5 Key Factors to Consider News For the First Time, The FDA Group Appears on Vault’s 2018 Rankings for Best Consulting Firms for Work/Life Balance News For the Third Time in a Row, The FDA Group Appears on Inc. 5000 List of America’s Fastest-Growing Private Companies News Medical Device Submission & Filing Fees Are About to Rise Significantly FDA Warning Letters FDA Warning Letters in 2017: A Mid-Year Trend Report GxP 4 Ways ICH E6 (R2) 2016 Impacts Good Clinical Practice (GCP) Data Integrity Audit Trail Requirements in Electronic GxP Systems: A Quick Guide Medical Devices Ensuring MDSAP Readiness Through a Preparatory Audit News The FDA Group's Brie Stoianoff & Husband Kevin Byrne Discuss Their Mission to End MS on Portland Today Medical Devices 3 Ways to Prepare for the MDSAP Internally Medical Devices [Free Webinar] Preparing for the Medical Device Single Audit Program In the News The FDA Group's Larry Stevens to Baltimore Sun: The Regulatory Path to Warning Labels for Acid Reflux Drugs Quality Standards CSV & Remediation: 6 Components of a Successful Program FDA Form 483 Using Quality Risk Management to Cultivate a Culture of Quality FDA Form 483 5 Steps to Ensuring CAPA Compliance Quality Standards An Ethical Framework for Enterprise-Wide Data Integrity FDA Compliance 6 Ways to Ensure Data Integrity in FDA-Regulated Industries FDA Auditing Audit Trail Checklist: 8 Questions to Ask When Configuring GMP QC Laboratory Audit Trails Data Integrity [Free Recorded Webinar] Ensuring Enterprise-Wide Data Integrity in FDA-Regulated Industries Medical Devices The Anatomy of an MDSAP Audit FDA Warning Letters FDA Warning Letters in Early 2017 Highlight Need for GMP Audits at Foreign Sites Medical Devices ISO 13485:2016 & MDSAP: How to Prepare Your QMS Now Process The Data Integrity Triad: A Framework for FDA-Regulated Manufacturers News 6 Key Medical Device Provisions in the 21st Century Cures Act News FDA Issues Final Guidance Covering CGMP Requirements for Combination Products FDA Warning Letters Inadequate CAPA Tops List of Compliance Problems for Medical Device Companies in 2016 In the News 3 Important Changes in FDA's Final Guidance for Postmarket Medical Device Cybersecurity Process How the 21st Century Cures Act Will Accelerate Medical Device Approvals Process A Risk-Based Approach to Managing Supplier Quality Process FDA Guidance Clarifies Quality Agreement Expectations for Drugmakers News NH-ISAC, MDISS & FDA Announce New Medical Device Cybersecurity Initiatives FDA Compliance Qualifying Suppliers & Managing Quality in FDA-Regulated Industries [Webinar] Process Does My Modified Medical Device Require a New 510(k)? Process Risk Management & Medical Devices: 4 Common Problems to Avoid In the News Medical Device Cybersecurity: New FDA Recommendations for Manufacturers FDA Programs Longer Orphan Drug Review Times: Advice for Manufacturers News Press Release: The FDA Group Appears on Inc. 500 List of America’s Fastest-Growing Private Companies for the Second Year in a Row In the News Press Release: The FDA Group Hires Industry Expert Brie Stoianoff as Director of Quality & Service Assurance News Adopting FDA’s Benefit-Risk Approach to Medical Device Compliance & Enforcement Decisions Medical Devices 6 Supplier Quality Mistakes FDA-Regulated Companies Should Avoid FDA Warning Letters 6 Reasons to Get Expert Help When Handling Warning Letters & FDA 483 Process A 5-Step Guide to FDA Warning Letter Recovery News CEO One on One with The FDA Group President, Nick Capman FDA Warning Letters 9 Top FDA 483 and Warning Letter Problems for Device Companies in 2015 News Press Release: The FDA Group Ranks #3 on Boston Business Journal's "FAST50" 2016 Process 8 Key Points from The FDA’s Draft Guidance on Data Integrity and CGMP Compliance News The FDA’s Final Quality Metrics Guidance: 3 Smart Ways to Prepare Now FDA Warning Letters 3 Key Elements of a Successful CAPA System FDA Warning Letters 3 FDA Warning Letter Trends for 2016 Process The Quick Guide to FDA Part 11 Compliance Process 5 Ways to Identify the Root Causes of Regulatory Compliance Issues FDA Warning Letters 5 Common Mistakes to Avoid in Your FDA 483 Response 510K PROCESS 6 Mistakes to Avoid When Submitting a 510(k) to the FDA FDA Presents Guidance Agenda for 2016 How to Prepare Class II Devices for Compliance with The FDA’s UDI Mandate FDA Warning Letters 5 Indirect Costs of an FDA Warning Letter Process 4 Things the FDA Looks for in Quality Metrics Process Meaningful Use Program Suspended: What You Need to Know In the News 3 Things to Expect from the CDRH in 2016 and 2017 FDA Programs How a New FDA Program Helps Pharmaceuticals Implement Emerging Technology FDA Warning Letters 10 Key Elements of an FDA 483 Response Regulations FDA Group’s Larry Stevens Finds Major Issues With Sen. Cruz’s FDA Overhaul Proposal FDA Warning Letters The 3 Ingredients of an FDA-Compliant Tweet Process 3 Parts of a Comprehensive GCP Quality Audit Process How to Choose the Right Expedited FDA Approval Program Compliance Consulting The FDA Group President Nick Capman Interviewed at Vistage Executive Summit 2015 Process Laboratory Developed Tests: Issues and Anticipated Regulations Process The Latest on the Generic Drug User Fee Amendment Process FDA Postapproval Issues: An Overview Process New FDA Proposal for Quality Metrics Process The FDA and Nanotechnology Process Personalized Medicine and the FDA Process How to Handle Reporting of Adverse Events Process 5 Steps in Developing Remediation Projects Process What Is a De Novo Classification? In the News Press Release: The FDA Group Ranks No. 294 on the 2015 Inc. 500|5000 List Process The Section 513(g) Mechanism Explained Process What to Consider When Designing Human Factor Studies Process How the Orphan Drug Act Offsets Treatment Development Costs Process 4 Important Features of Compliance Training Systems Process What is an Investigational Device Exemption? FDA regulatory consultants 3 Advantages of Working with an FDA Consulting Firm Medical Devices A Basic Guide to the Medical Device Single Audit Program In the News What You Should Know About Compounding Pharmacy Laws Process What To Do If You're Issued a Form FDA 483 Medical Devices New UDI Regulations: What You Need to Know

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