EU MDR Implementation
Regulatory Compliance Associates® (RCA) MDR consulting service offerings to Assist Existing/New Clients with Implementation of the EU MDR requirements.
- 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
- 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
- Staff Augmentation
- Readiness Audits / Pre-Certification Audits and/or Assessments
- 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
Regulatory Compliance Associates (RCA) provides medical device consulting to the following industries for the resolution of life science challenges:
- Life Sciences
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
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, Health Canada, MHRA, and globally regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health®
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
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