Medical Devices

Regulatory Strategy

Our goal is to provide medical device developers and manufacturers with sound regulatory strategies to facilitate market delivery, in a timely and cost-effective manner. Compliance Gurus can provide medical device organizations with a comprehensive plan to ensure adherence to the requirements of the Federal Food, Drug and Cosmetic Act, FDA regulations/guidances and applicable conformance standards.

We offer guidance on all aspects of the product development lifecycle, from pre-submission planning, through post-market reporting and promotion.

Pre-submission services include, medical device classification, human factor & usability testing, clinical trial design and methodology to support marketing objectives, conformance standard design, planning & execution, and labeling & packaging guidance.

Post-marketing surveillance services include, UDI (Unique Device Identification) design and implementation, product complaint design, and MDR (Medical Device Reporting) adverse event categorization and reporting protocols.

Advertising and promotional services include, the generation and review of multimedia post-marketing materials, to ensure compliance with FDA and FTC advertising & promotional regulations and guidances.

In addition, we are happy to assist domestic and foreign medical device designers, manufacturers and distributors, with FDA establishment registration, medical device product listing, and import/export regulatory requirements.

Submissions

We have aligned ourselves with the most prominent and experienced medical device submission specialists and negotiators in the country. We are proud to offer IDE (Investigational Device Exemption), PMA (Premarket Approval), and 510k (Premarket Notification) submission services.

In addition, our professionals are available to advise on CE marking, and author Technical Files and Design Dossiers for the European market.

cGMP (current Good Manufacturing Practices)

The Food, Drug and Cosmetic Act mandates all medical device designers, manufacturers, packagers, holders, labelers, installers and servicers to comply with good manufacturing practices. Compliance Gurus can update and improve your existing quality management system, in conformance with contemporary, 21 CFR 820, regulatory requirements and FDA/ICH guidances. In addition, we are experienced at developing and implementing streamlined, cost-efficient quality plans for small businesses and start-ups.

Part 11

Medical device organizations utilizing electronic systems to create, modify, maintain, archive, retrieve or transmit data records, mandated by the Federal Food, Drug and Cosmetic Act or FDA regulations, must comply with 21 CFR 11. Part 11 also applies to recordkeeping measures, which assign electronic signatures. Compliance Gurus can conduct a Part 11 assessment of your company’s electronic records and signatures, and revise or implement a compliant Part 11 protocol.

Computer System Validation

Compliance Gurus can assist your organization with your computer system validation needs.
We are experts at qualifying infrastructures and validating computerized systems, ranging from small desktop applications, through enterprise-wide applications deployed for global use. Furthermore, our staff has substantial experience validating a variety of GLP, GDP, GCP, and GMP systems and software applications.

Solidworks™ VARS (Value-Added Resellers)

We are a Solidworks™ software endorsed company that provides compliance and validation services to value-added resellers and their clients. Compliance Gurus was exclusively selected to create a FDA Validation Kit to be used in conjunction with the Solidworks™ EPDM (Enterprise Product Data Management) tool. The Kit is designed to expedite computer system validation for EPDM software and address, 21 CFR Part 11, Electronic Records and Electronic Signature requirements.

Auditing

The Compliance Gurus team are experts at auditing internal and external regulatory systems, processes and procedures. Whether you are preparing for an FDA Pre-Approval Inspection, have received a FDA 482: Inspection Notice, or want to perform an FDA mock audit, as part of your inspection readiness plan, we can assist you. We can provide a detailed, comprehensive gap analysis of your company and vendor regulatory requirements, to identify compliance related deficiencies. Upon discovery, regulatory gaps will be analyzed, from a risk management perspective, and can be addressed through the implementation of a corrective and preventive action plan.
Our auditing services span the entire medical device development and quality management lifecycle. We frequently audit 3rd party vendors, including contract research organizations, contract manufacturing organizations and contract packaging organizations.

Training

Compliance Gurus can provide employee training to small and large groups. All of our corporate trainers possess advanced degrees and have ample years of experience working in the FDA regulated industry. Medical device organizations can customize their educational curriculum, by choosing from our comprehensive selection of FDA and medical device related content.

Currently, our training topics include: FDA History, The Organization of the FDA, History of Medical Device Regulation, Good Manufacturing Practices for Medical Devices, Medical Device Advertising & Promotion, and Current Trends in Medical Device Regulation.

FDA Interaction and Remediation

Direct interaction with the FDA is a stressful, apprehensive experience, even when conducted under the best of circumstances. Compliance Gurus is available to alleviate your corporate anxiety, by offering support during this challenging time. If you are preparing for a Pre-Approval Inspection or have received a Form 482: Notice of Inspection, we can prepare you for the audit by providing pre-inspection guidance. In addition, we are available to accompany you, during the inspection, to help mediate any points of contention between the parties.

Compliance Gurus offers comprehensive remediation services for organizations receiving a Form 483 or Warning Letter, after FDA inspection. We can structure and implement an effective remediation plan to efficiently address any compliance deficiencies or violations. If your company has received a Warning Letter, we can author a satisfactory Company Response and devise a corrective action plan, in adherence to the 15-day response timeline.

In addition, our consultants are available to assist corporations with the logistics, which may arise from a voluntary or FDA mandated product recall.