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Design History File Support Services

From launch to lifecycle, RCA assists in ensuring device compliancy. We offer expertise in helping you navigate through new product development and remediating legacy Design History Files (DHFs) within the complex and evolving regulatory environment.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Design History File Support Services

Design History File Support Services

From Launch to Lifecycle, RCA Assists in Ensuring Device Design History

We offer expertise in helping you navigate through new product development and remediating legacy Design History Files (DHFs) 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 DHF 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)

About RCA

Design history fileRegulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

  • Founded in 2000
  • Headquartered in Southeastern Wisconsin, with offices in West Central Florida; North Central Colorado; and Central Eastern Europe
  • Expertise backed by over 500 industry subject matter experts

Mission Statement

Regulatory Compliance Associates® Inc. is driven to improve the overall health and well-being of patients around the world by providing expert consulting services tailored to the business needs of its clients.

The RCA Global Difference

  • We are the consultants who know how to get things done with quality results, on time and on budget.
  • Our expert resources are a strategic blend of top industry veterans, experienced specialists, and stellar consultants to support any project need.
  • Our management leaders each have two to three decades in FDA-regulated industries.

We have walked the walk.

  • Our approach is differentiated to meet your specific needs.
  • We can provide excellent references, case studies, and testimonials.
  • Our strategy to execution is priced appropriately.

Why Choose RCA

  • RCA is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges.
  • By mining regulatory intelligence, RCA continuously evaluates FDA’s current thinking and leverages thought leadership networks to advocate for our clients.
  • We know a quality or compliance crisis can significantly impact your business. We have the experience to manage them.
  • We have the know-how and proven approach to navigate warning letters, consent decrees, and other situations.
  • We know how to partner with your executive, legal, and communication teams.
  • We support management to assist with the growing and changing concerns.
  • We help navigate the storm and manage the impact to your business.

Interested in Learning More?

Contact Us

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