Expert Resource: LEADING MEDACCRED EXPERTS

Expert Resource is the leading provider of MedAccred and Nadcap consulting services.  100% of our clients (hundreds) pass their first attempt at certification with PRI.  Most of our consultants are spread throughout the United States, England, and China, but we have also helped companies in over 10 other countries.  Headquartered in California, we will go anywhere to help you. 

MedAccred consultants must be (1) technical experts in their fields (ex: Welding, Plastics, Heat Treating, Sterilization, Electronics, etc.) and (2) experienced experts with the MedAccred requirements, many of which are still developing.  Most of our competitors are ISO 9000 consultants with some vague understanding of Nadcap or MedAccred and very little experience in those specific fields.  Be careful not to use someone who claims to be able to simply "interpret any standard".  MedAccred requirements are very technical and your consultant should be a technical expert with decades of experience.

Our MedAccred consultants are Lead Auditors, which means they are the authorities.  They are trained by PRI (the authority approved by all the OEM's and Primes) and have hundreds of audits in their repertoire.  Be sure you are relying on the best because they will utimately affect not only your certification success but more importantly they will be modifying how your company operates.   It is critical.  Don't leave your company in the hands of a novice.  Our previous history with Nadcap and MedAccred audits (with clients of various sizes with various special processes) often result in 2 or less minor findings per audit, some of which are flawless audits.  Does your MedAccred consultant have a proven success record? 

Expert Resource provides MedAccred consulting and training services

MedAccred is based on Nadcap, the leading worldwide cooperative program of major companies designed to manage a cost-effective consensus approach to special processes & products manufacturing and testing specifications and provide continuous improvement within the aerospace and defense industries.  MedAccred takes these principles and applies them to the medical device industry. 

MedAccred process and product certification is provided by Performance Review Institute. PRI is the only auditing company approved by the medical device industry to offer official certification audits. 

Expert Resource provides the consulting and training to prepare your company for successful MedAccred certifications with PRI. 

Expert Resource provides:

• Introduction to MedAccred training (how to plan, how to avoid pitfalls, how to earn merit, lessons learned, fundamental requirements of the program, what to expect)
  
• Gap assessments with reports including recommendations for how to correct each finding
• Document development (manuals, procedures, work instructions, audit checklists)
  
• MedAccred special process internal auditing and/or internal auditor training
• NCR (corrective actions) consulting services to prepare a company for the PRI MedAccred audit
• 100% of our clients pass their first attempt at certification!

Funding: Many of our clients qualify for State and/or US Federal funding for training, consulting and auditing services. This reimburses costs associated with consulting and registration. Please contact us for more information.

MedAccred Special Processes / Programs

There are various MedAccred quality standards for different products, manufacturing processes and services. Please click on any of the standards listed below for a more detailed listing.  ER specializes in every category of MedAccred certification. 

• Medical Quality Systems

• Cable & Wire Harness

• Heat Treating


• Plastics


• Printed Circuit Board Assembly

• Sterilization

• Welding

To view the MedAccred Audit Checklist Listing, please Click Here.

Why become MedAccred Accredited?

There are two primary reasons for seeking accreditation. The most obvious reason is that your customer is making accreditation mandatory for doing business. The second reason is because the various standards will ensure that consensus-based best practices are implemented for increasing quality of a product process or service. 

How do you implement MedAccred?

Expert Resource provides a step-by-step roadmap for accreditation. Because MedAccred requires certification to an approved Quality Management System standard as a pre-requisite, the first step is typically to implement ISO13485 or AC8004 (MedAccred Quality Management Systems). AS9100, ISO 9001, and IATF 16949 may also be acceptable pre-requisites for MedAccred depending on the Task Group requirements.  ER specializes in the integration of these requirements with comprehensive training, consulting and document development.

After conformance with one of these Quality Management Systems, the next step is for ER to perform a MedAccred gap assessment to one or more specific products, processes or service standards/specifications/audit checklists. The result is a gap assessment report, which will identify each objective finding, its interpretation for your company’s specific operations, and recommendations for corrective actions. This gas assessment report will dictate the customization of an Expert Resource proposal for MedAccred-specific implementation.

ER will provide hands-on assistance for each MedAccred program, which may include a gap assessment, process development, training, internal audit, PRI MedAccred audit preparation and any assistance with NCR corrective actions and challenges.

Expert Resource’s roadmap to MedAccred Certification will put you on the road to success. By contacting ER, you are ensuring that your MedAccred system will be done right the first time with experts in your industry. ER will expedite your timeline to accreditation and will minimize your internal business disruption with our hands-on approach.

MedAccred Root Cause & Corrective Action Training

ER provides a four to eight hour session of on-site training for non-conformance reporting with root cause analysis and corrective action training (NCR-RCCA). Alternatively, we also offer this course once per month in our Huntington Beach, CA, USA office for individuals and small groups with materials included. Click here to learn more. 

Lack of proper NCR-RCCA training is the area of MedAccred compliance in which most companies will fail, adding unforeseen costs to the program and building months of frustration. To prevent MedAccred audit failures and build on the MedAccred Merit Program (reducing auditing costs), ER highly recommends that all Top Management, Quality Personnel, and MedAccred-related process personnel attend this training session. 

Each session will allow a maximum of 20 trainees. PRI has a very stringent and particular format for NCR-RCCA. MedAccred requires that teams of employees work together on each NCR-RCCA found during the PRI audit. Therefore, teams should be trained together, have a common approach and unified expectations. Training will utilize overhead projection, hand-out materials, and be supplemented with a sample 19-step RCCA work instruction. The work instruction may be modified to meet your exact needs.