Noblitt & Rueland, for over 23 years, has been a leading consulting and training firm to manufacturers in the medical device, pharmaceutical, and biotech industries. We specialize in technical FDA & ISO regulatory and quality issues including Quality Systems, Design Control, Risk Management, Software, Electrical Safety Standards, Electronic Recordkeeping & regulatory consulting for FDA & Internationally regulated medical industries.
Introduction
Noblitt & Rueland services help companies get compliant medical products on the market quickly and help companies continue to stay out of regulatory trouble. We also help companies when non-compliance or FDA enforcement issues arise. We do all of this by offering highly skilled and experienced consulting assistance; as well as, teaching training programs that meet the requirements of FDA & international regulations.In-house training seminars are offered on numerous FDA/ISO issues and are taught at your facility with all discussions held in confidence. We have listed a sampling of our consulting services and training courses below. Please note that our services can standalone or integrate seamlessly with your current RA/QA and R&D efforts.
Consulting / Implementation / Audit Services
Quality System (FDA 21 CFR Part 820 & ISO 13485)
Mock FDA audit / inspection
Internal Auditing
Design Control
Risk Management (ISO 14971)
Software Quality Assurance
Software Verification & Validation (V&V)
Complaint handling & Medical Device Reporting (MDR)
Submissions 510(k), PMA, IDE, CE Mark Technical File
FDA enforcement resolution & remediation (FDA 483, Warning Letter, Recalls, etc.)
Device Safety (IEC 60601-1, including collateral standards e.g. IEC 60601-1-6, IEC 60601-1-8, etc.)
In-house Training Courses / Seminars
FDA Quality System Regulation (QSR/GMP) & Inspections
Design Control, the FDA & ISO
Risk Management, ISO 14971 and FDA Requirements
Software, the FDA & ISO
Software Verification & Validation Strategies
FDA Electronic Recordkeeping & Signatures (21 CFR Part 11)
510(k) Submissions: Getting to Market
CE Marking Medical Devices, MDD, IVD, & AIMD
IEC 60601-1 the 3rd Edition: Medical Device Safety Requirements
Auditing Quality Systems for FDA & ISO Compliance
ISO 13485:2003 Implement & Maintain
Writing Effective Technical Product Requirements
Labeling Requirements for Medical Devices
Quality System Implementation, Auditing, Corrections & Refinement
The Noblitt & Rueland consulting team has extensive experience in the development, implementation, and correction / remediation of quality systems in FDA regulated companies, including medical device firms, ranging in size from a staff of one to thousands. Both start-up companies needing a quality system and companies found to be noncompliant by the FDA during an inspection have benefited from this experience. Our specialists have developed Quality Systems that meet both the FDA Quality System Regulation requirements and ISO 13485 for Europe & internationally. Numerous clients utilize our auditing services to fulfill the FDA & ISO regulatory requirement for periodic internal audits and include Gap Assessments as well as Mock FDA audits / inspections to prepare the company for a FDA inspection.
Product Submissions & Regulatory Strategy
Our consulting team has extensive experience in the development and submission of 510(k), CE Mark Technical File, PMA, and IDE submissions. The quality of our submissions greatly reduces the regulatory review time and reduces the likelihood and quantity of Additional Information (AI) requests that can substantially delay a submission clearance or approval. We also assist companies understand and determine a regulatory strategy for accomplishing their marketing and business objectives. In addition, we offer regulatory due diligence investigations that have proven beneficial to potential investors or firms acquiring medical devices, companies, or technologies.
Product Experience includes all Device Classifications
Noblitt & Rueland extensive medical product line experience includes Class I, II, III, monitoring, diagnostic, in-vitro diagnostic (IVD), and therapeutic critical-care medical devices including pediatric devices along with combination devices associated with pharmaceuticals and biologics. A very brief sampling of our medical product experience includes clinical chemistry analyzers, immunoassay analyzers, microbiology analyzers, phaco-emulsification systems, implantable & external defibrillators, software only devices, pacemakers, glucose monitors, cardiac output computers, ejection fraction computers, oxygen saturation computers, retroperfusion pumps, cardiac imagers & mapping systems, EKG monitors, catheter-sensor interfaces, home healthcare monitoring devices, ventricular assist devices, ventilators, PACS systems, brachytherapy systems, implants, surgical garments, infusion pumps, infusion tubing sets, radiation treatment therapy planning systems, electronic recordkeeping systems, as well as, automated systems used in manufacturing process instrumentation and quality systems implementation.
Regulatory & Compliance Experience Advantage
Most Noblitt & Rueland associates have twenty plus years experience in various aspects of medical device development and manufacturing for healthcare industries. Our team includes specialists that have been directly involved in developing and implementing strategies for solving FDA and International regulatory and compliance issues.