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.
Our clients are very diversified in size,
special process expertise. We have met the needs of the largest OEM's and very small job
shops alike. Our prices are highly competitive and our consultants are very
personable. We specialize in every area of MedAccred and we
guarantee our work.
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
consultants with some vague understanding of Nadcap or MedAccred and
experience in those specific fields. Be careful not to use
who claims to be able to simply "interpret any standard".
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?
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
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.
Resource provides the consulting and training to prepare your company
for successful MedAccred certifications with PRI.
ER offers a training course, one for each of the MedAccred Special Processes, tailored to that special process audit
criteria. These classes are provided on-site customized to your exact
needs to prepare your company and employees to implement and pass the
rigorous MedAccred audit.
- 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)
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
(corrective actions) consulting services to prepare a company for the
PRI MedAccred audit
- 100% of our clients pass their first
attempt at certification!
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
for more information.
Special Processes / Programs
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
To view the MedAccred
Audit Checklist Listing, please Click
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
do you implement MedAccred?
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
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.
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.
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.