Archives: Visual Resources

Medical Device Regulatory Services

Trust the Medical Device Regulatory Experts

 

Whether struggling with a submission strategy and execution or dealing with regulatory compliance, we stand ready to support your medical device regulatory services needs. Our consultants have years of experience as regulatory and compliance leaders and can help establish solutions for any challenges that surface.

Our services highlighted in the handout include:

  • US FDA Traditional Regulatory Strategy and Submissions, such as PMA and 510(k)
  • Innovative Regulatory Pathways such as De Novo Requests
  • Humanitarian Use Device (HUD) and Device Exemption (HDE)
  • FDA Pre-Submission Meeting preparation and support
  • European Union Technical Files and Class III Design Dossiers
  • Clinical Evaluation Reports
  • Global regulatory strategy and product classification
  • Global registration submissions

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

ISO 13485 & 21 CFR 820

ISO 13485 comparison matrix to 21 CFR 820

Understanding the similarities and differences between ISO 13485:2016 and CFR 21 Part 820 is a key step toward creating and / or maintaining a robust and comprehensive global Quality Management System (QMS).

Our Comparison Matrix provides a summary overview of the regulation and the standard in a simple and easy-to-use table format.

What is your QMS and how does it stand up to the International Standard and applicable regulatory requirements? Who determines the processes, sequences, and interactions of these ISO 13485:2016 processes? View our chart and compare how close—or far—you are to meeting QMS regulations for your device.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

EU MDR Implementation

Regulatory Compliance Associates® (RCA) MDR consulting service offerings to Assist Existing/New Clients with Implementation of the EU MDR requirements.

  1. Perform a Comprehensive Review of Client’s Entire Product Portfolio:
    • Confirm whether any Legacy Products and/or Modified Legacy Products have been affected by the new MDR Definitions and/or Reclassification of certain types of products
    • Prepare Product Rationalization Strategy Reports
    • Check the status of MDD Certificate expiry dates and prepare an EU MDR Certificate Compliance Strategy for each product expiry date and prepare an EU Compliance Strategy for each device
  2. Remediation and Implementation of EU MDR Compliance Plan
    • Supply Chain Requirement
    • Development/Implementation of an Compliance Plan for systems and devices
    • Remediation of Compliance Gaps
    • Development/Implementation of EUDAMED Database compliance plan
  3. Staff Augmentation
    • Readiness Audits / Pre-Certification Audits and/or Assessments
  4. Perform a Gap Assessment of the current Quality Management System (QMS) and its Current Processes and Procedures Compliance
    • Labeling requirements
    • Enter regulatory data into the EUDAMED Database
    • Post-Market Surveillance System (PMS)
    • FDA Unique Device Identification (UDI) System
    • Clinical Data
    • Vigilance Activities
    • Market Surveillance Activities
    • Safety and Performance

 

Design History File Info Sheet

From Launch to Lifecycle, RCA can support your Design History File

We offer expertise in helping you navigate through new product development and remediating legacy Design History File (DHF) files within the complex and evolving regulatory environment.

From launching a new product to market in accelerated timeframes to updating the design information necessary to validate and maintain the device throughout its lifecycle, we have a thorough understanding of the specific design history requirements for U.S. and international medical device industries to ensure regulatory compliance and drive business best practices.

In addition to design history file content, development, and management, download our handout to view more of our DHF-related support services, including:

  • Quality System Regulation, 21 CFR Part 820
  • The Design Control requirements of the CGMPs, 21 CFR 820.30
  • Device Master Records (DMR) and Device History Record (DHR)
  • The EU’s Medical Device Regulations (MDR) including Technical File / Design Dossier
  • Risk management (ISO 14971) for medical devices including risk analysis, FMEA, risk evaluation, and risk controls through Corrective and Preventive Action (CAPA) plan and design control requirements
  • IEC 60601-1-11 (2010) including Programmable Electrical Medical Systems (PEMS) (Clause 14)
  • Total product life cycle (TPLC)

 

Outsourcing Quality & Regulatory

Learn About the Benefits of Outsourcing 

Outsourcing Leadership has become an increasingly common practice in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies because needs may vary greatly depending on the life cycle of the organization.

Outsourcing strategic management can provide a better match to changing QA / RA strategic needs through the company life cycle. Regulatory Compliance Associates® Inc.’s interim management strategy brings needed expertise while saving costs.

 

FDA Medical Device Services

Audit, Assessment & Inspection Services

A regulatory audit and compliance gap assessment are essential in identifying product, process and system deficiencies, risk assessment, and inspection readiness. Our FDA veterans and medical device consulting experts use a gap assessment risk-based approach to help you select the best FDA audit or inspection solutions.

 

About RCA’s Medical Device Consultants

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA’s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

Our team of over 500 industry experts — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.