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The Expertise


Your FDA Quality and Regulatory Solutions

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The Expertise


Your FDA Quality and Regulatory Solutions

ABOUT US          

Former FDA and Industry Experts Providing Pre-market, QSR and Post-market Services

Boyce Consulting provides personalized, cost-effective FDA and ISO regulatory and quality solutions and training to small and large companies, initial importers, contract sterilizers, laboratories and entrepreneurs.

We do not charge a monthly retainer fee  like large consulting companies to keep you a high priority!

Boyce Consulting has helped approximately 180 small and large companies, and entrepreneurs comply with FDA regulations, project planning, system corrective actions, 510(k) submissions, FDA strategic planning, due diligence audits, labeling reviews, process and test method validations, development and execution of risk management processes and compliance with 21 CFR 11.

Our Goal is to help you become compliant, trained, self-sufficient and consequently, self-sustaining.

 

 

We have successfully audited

we have obtained permission to market

WE HAVE DEVELOPED AND IMPLEMENTED

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Medical device manufacturers, IVDs, sterilizers, laboratories and initial importers.

Medical device 510(k)s

Compliant quality systems for Medical device manufacturers, IVDs, sterilizers, laboratories and initial importers.

 

 

our work

If you are wondering what the next step is in regaining your standing or solving any problem with the FDA, Our Consultants will work with you and your staff to resolve pressing compliance issues.  Where you may be unsure or hesitant on how best to proceed, we provide guidance based on decades of experience.  

We can help you interface with the FDA  directly or we can provide effective communication and planning documentation necessary to get your firm back into full compliance. 

We can also help you streamline your processes using various quality methods such as process mapping to eliminate document and method redundancies, but also improving compliance.

We also help you stay FDA and ISO prepared by teaching you how to sustain your quality system via an established  CAPA process that requires monitoring and analyzing meaningful quality metrics that become inputs to the Management Review Process. Gap analyses and audits also help you sustain your quality system. Boyce can assist you in establishing effective gap analyses and FDA-mock audit processes.  
 

we can help with all phases and 510(k) submissions

RISK-BASED QUALITY SYSTEM, MONITOR QUALITY METRICS,  MEANINGFUL MNGT. REVIEWS

Develop, train and implement

monitor quality metrics, MEANINGFUL MNGT. REVIEWS, GAP ANALYSES/AUDITS


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The Challenge


your competitors are on the move. FDA is on the move. Are you?

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The Challenge


your competitors are on the move. FDA is on the move. Are you?

THE FDA IS CHANGING. THE LAWS and POLICIES GOVERNING REGULATORY AND QUALITY ISSUES ARE CHANGING. ARE YOU PREPARED?

  • Are you familiar with FDA's higher expectations regarding Purchasing Controls?
  • Do you know FDA has announced it is progressing towards a more specialized organizational structure including investigators?
  • Do you know how to determine the difference between a Recall and a Market Withdrawal?
  • Have you consulted and completed the applicable  "Refuse to Accept" Checklist for your 510(k) submission?
  • If you are an initial importer, do you understand the 510(k) indications for use vs. what your labeling states?
  • Do you need help with any FDA problem?
  • Do you have effective and efficient QSR processes that prioritize utilization of resources rather than "all quality issues are equivalent"?
  • Do you need help with any premarket submissions?
  • Do you have an appropriate Risk Management Program that will also support the rest of your quality system?
  • Do you have an applicable employee manual for new employees?
  • Do you have a training program that manages and provides a retraining schedule?
  • Are your sales and marketing personnel well versed in MDR regulations and your internal complaint handling procedures?
  • Is your engineering staff up-to-date on design controls, product and process validation and risk management?
  • Are you 21 CFR Part 11 Compliant?

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The Strategy


Prevent & Sustain, or Correct if there are Problems

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The Strategy


Prevent & Sustain, or Correct if there are Problems

whether fda has visited or not, Boyce can help

 

 
 

 

We can train you in prevention & sustainability:

Boyce Consulting knows and teaches that preventing in-house quality, regulatory, and product problems before they arise is a primary key to prevent unnecessary severe expenses, penalties and delays. We can teach you how to be "audit ready" at all times. Sustaining compliant quality and regulatory processes is then key. We provide and teach you prevention and sustainability practices.

However, if a third party regulatory body has stepped in, we can help you solve your problems applicable to your situation. 

We customize our services to you based on your situation. You are not just a "project number" to us.

 

Some of the preventive measures we provide are:

  • Gap Analyses and Audits; 
  • Audits for Due Diligence;
  • Design and Process FMEA review, development, and execution;
  • Company and/or Facility-Wide Improvement Action Plans; 
  • Ensure 510(k) labeling and technical support docs match current information;
  • 510(k) development and submission;
  • Process validation and optimization using applicable statistical techniques; 
  • Test Method Validations;
  • Personnel training; 
  • Corrective and Preventive action program development with applicable metrics and execution;
  • Internal auditing program development and execution;
  • Evaluation for streamlining/improving current quality systems;
  • Management Reviews with Applicable Metrics;
  • Reviewing and ensuring your supplier contracts have all required quality and regulatory information.