Manufacturing Optimization and Aging Facilities

Optimizing every business practice is essential to further your company’s success. However, when reviewing their efficiency, many companies overlook one of the most vital processes in the medical device industry — manufacturing. The truth is, that critically examining your business’ manufacturing practices offers exceptional benefits to your bottom line. Manufacturing optimization can also ensure your compliance with regulatory bodies and your product’s effectiveness and safety for its end users. Optimizing your processes and facilities for the automated age is crucial.


Regulatory Compliance Associates® Inc.’s strategic consulting services extend to manufacturing process optimization for maximum impact on your bottom line, manufacturing automation for adequate validation of equipment, and validation process for aging facilities to ensure quality, cleanliness, compliance, and safety.


Our team has an average of 25 years of industry experience making sure businesses are practicing the most effective manufacturing methods possible. We’re excited to extend this expertise to your company. Whether you operate a small U.S. or international startup or a major Fortune 100 corporation, we’ll help you enhance your quality standards and reduce your manufacturing processes — all while securing your workers’ and users’ safety and your products’ compliance.


Manufacturing Process Optimization


Our comprehensive evaluations will identify opportunities that consistently yield a sustainable return on investment. We will help you identify opportunities for:


  • Reducing Set-Up Times
  • Increasing Throughput
  • Reducing Inventory Levels
  • Lab Efficiency Improvements
  • Scrap and Waste Reduction
  • Cycle Time Compression
  • Capacity Creation
  • Process Automation
  • Cost Reduction


We provide the following manufacturing optimization services:


  • Program Analysis
  • Process Optimization through Engineering Studies
  • Statistical Process Control
  • Lean Innovative Product / Process Solutions
  • Value Stream Mapping
  • Kaizen Events
  • Design for Six Sigma
  • Inventive Problem Solving




Our manufacturing automation expertise includes:


  • Development of Validation Documentation
  • Validation Services
  • Risk Assessments


Aging Facilities


Offering innovative solutions with hands-on validation support, we ensure that your aging manufacturing facility continues to meet all regulatory and client requirements, without an adverse impact on the finished product.


  • HVAC Systems and Associated Controllers
  • Medical Gas Systems
  • Plant and Pure Steam Systems
  • Water Systems including USP, RO / DI, and WFI
  • Compressed Air Systems
  • Controlled Environments


Choose Manufacturing Consulting Services From RCA


When you review your manufacturing processes, you’ll find areas you’ve never before considered that you can improve upon. Improving these business facets ensures your continued safety, compliance and overall savings — and both your business and the users who depend on your products will thank you. But evaluating your business practices on your own can be confusing. Instead, turn to trusted medical device consultants like RCA®.


We employ an extensive team of more than 500 medical device specialists and past FDA employees. Each of these individuals has the skills and experience needed to keep your manufacturing facilities running smoothly according to regulatory requirements and current manufacturing best practices. Whether you need to maximize your manufacturing practices’ efficiency or ensure your aging facility’s safety and compliance, they’ll be here to help you pinpoint any concerns and map a clear road to success.


RCA® Inc.’s medical device manufacturing consulting services help you work smarter, faster and safer to create products your customers will value. Contact us today for more information or to request manufacturing consulting for your medical device company.


About Regulatory Compliance Associates


Regulatory Compliance Associates (RCA) provides healthcare consulting 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, 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.



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. 



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