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Way Back in 2012 the International Medical Device Regulatory Forum (IMDRF) Work Group developed a MDSAP standard called Medical Device Single Audit Program. These are a set of requirements for auditing organizations performing regulatory audits of medical device manufacturers’ and their quality management systems.
The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.” [International Medical Device Regulators Forum Medical Devices Single Audit Program, International Coalition Pilot Program sheet, January 2014]
The MDSAP standard is based on ISO 9001:2008 with 8 element structure unlike ISO 9001:2015(10 element structure). International Standard MDSAP specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. The MDSAP certification provides a different kind of approach in the manufacture and distribution of medical equipment and there is no doubt that many medical practitioners have preferred equipment from providers and producers who have been certified by the MDSAP standard. The standardization criteria are a global initiative that aims at creating a professional medical equipment production through world class management practices that are all within the MDSAP compliance, medical device standard.
The rational that is taken in the MDSAP audit for compliance involves manufacturing and distribution of medical equipment, as well as considering the potential risk that is involved in their use. The certification allows medical equipment manufacturers to meet global standards of safety in developed countries and comply with the existing legislation in those nations. The standard initiates management systems to analyze the production of medical equipment and to come up with instructions on how to strengthen weaknesses in the system.
The requirements for MDSAP certification are very basic and all aim at promoting high safety standards in the production and distribution of medical equipment.
For effective implementation for MDSAP standard, the organizations develop MDSAP audit checklists to conduct MDSAP Gap analysis, develop MDSAP training materials to disseminate to all interested parties related to MDSAP requirements, develop MDSAP Quality Management System, conduct MDSAP internal audits, using MDSAP audit checklists and conduct management review of the MDSAP Quality Management System for ISO 13485 standard compliance prior to MDSAP certification audit. Any organization seeking MDSAP certification may use MDSAP Consulting, MDSAP Auditing and MDSAP Training entities. A competent MDSAP consultant may be present during MDSAP certification audit to defend the established MDSAP Quality Management System without interfering with MDSAP certification auditors. To effectively manage MDSAP compliance several MDSAP Checklists such as MDSAP ISO 13485 Audit Checklist, ISO 13485:2016 Standard Checklist, FDA MDSAP Audit Checklist, MDSAP Quality Monitoring Checklist (First Article Inspection, Incoming Inspection, Factory Audit and Factory Acceptance Tests) and Essential Principles Checklist (Therapeutic Goods Administration)
Among the basic and fundamental requirements, the following are the most significant ones:
- MDSAP Standard requires that organizations develop and establish a quality medical equipment management practice and system in all sectors of production and distribution.
- MDSAP Compliance Calls for organizations to conduct comprehensive assessments of their production system to determine the strengths and weaknesses of their existing MDSAP medical devices, quality management system and further move on to develop possible solutions regarding their findings.
- MDSAP standard requires detailed presentation of the organization management system to make sure that all needs have been taken into close consideration.
- MDSAP standard also requires companies to implement and evaluate an internationally recognized quality management system in the production of their medical equipment.
- MDSAR compliance requires Maintaining and evaluating medical equipment quality management system, documentation of procedures as well as development of an effective Quality manual.
- MDSAP standard Promotes proper documentation of medical device services and equipment management practices.
Any facility offering Medical devices as Products or Services and is desirous of having a globally acceptable quality assurance system for medical devices needs to get certified to MDSAP/ 13485:2016
Any facility desirous of assuring customers about their quality systems and FDA compliance should get MDSAP certification.
Any facility desirous of having interests of all stake holders covered in their system and has adequate provisions for mitigating risks in their processes must get MDSAP Certification
Any facility desirous of having a strong marketing tool to showcase their quality capabilities for medical devices must get MDSAP certification
Any facility desirous of having a complete system which covers all aspects of operations in one single system for management review and comply with statutory and regulatory requirements must obtain MDSAP certification
Any facility whose management desires to have one single system for medical devices manufacturing or services, through which management can build teamwork, review progress, measure, monitor, make corrections and give impetus for continual improvement must get MDSAP Certification
- All facilities seeking MDSAP certification require a Medical Device Quality Management System (MDQMS). Developing a comprehensive system to meet all the requirements of MDSAP Standard for effective implementation to achieve desired results, a competent MDSAP consulting company or a competent MDSAP consultant is essential
- MDSAP consulting companies are required to have a MDQMS that is developed to comply with all customers and regulatory requirements and the organization can demonstrate that the facility has a robust system and can produce quality products and ensure safety for consumers
- MDSAP standard is an international standard presently accepted in Australia, Brazil, Canada, China, Europe, Japan and USA
- MDSAP Standard is dedicated to build MDQMS for medical devices of any class and pave way for continual improvement in any facility
- A competent MDSAP consulting company or MDSAP consultant can provide detailed explanation on the intent of the standard while developing an MDSAP compliant Medical Device Quality Management System(MDQMS)
- Prior to MDSAP certification facilities need to implement documented MDQMS for a minimum of 3 months and gather adequate data and records to show as evidence of conformity
- Once a MDQMS is ready, and implemented Internal audit is performed using MDSAP Audit checklists like Certification Body MDSAP Audit checklists.
- A competent MDSAP consulting company or MDSAP consultant can provide detailed coaching on how to conduct MDSAP Management review
- Managements of the facilities need to conduct one full scale review of the entire MDQMS and ensure its adequacy for their organization.
- Management Team needs to identify Action items to make corrections to any MDSAP requirement not being fulfilled
- MDSAP Certification Bodies conduct Audit in 2 stages. During Stage 1, MDSAP certification audit evaluates the documentation system and basic requirements of meeting MDSAP Standard Requirements
- MDSAP Certification Body returns for final MDSAP audit where all MDSAP Requirements are thoroughly audited to ensure that MDSAP standard requirements are met and documentary evidence exists to demonstrate MDSAP compliance
- Once MDSAP certification Body is satisfied, recommendation is sent to accrediting agencies to issue MDSAP certification
- Quality Systems Enhancement Inc. (QSE) is a Premier Consulting, Auditing and Training firm engaged in the field of MDSAP certification to international standards
- QSE has a unique 10 steps disciplined path for MDSAP certification which is insensitive to failure
- QSE has assisted over 700 facilities achieve MDSAP certifications
- QSE’s unique document simplification tools result in smooth implementation to achieve MDSAP certification
- QSE identifies all processes from “Quote to Cash” in other words all activities from submission of quote, processing of the order, quality control, dispatch to customer and receive cash. All manufacturing and non-manufacturing processes are covered
- QSE’ s documentation covers all requirements of customers and other interested parties, statutory and regulatory requirements related to MDSAP standard
- QSE provides simplified documented system is easy to integrate MDSAP standard to other management system standard
- QSE engages qualified and competent auditors to conduct MDSAP internal audits using MDSAP audit checklists
- QSE conducts internal audits using MDSAP audit checklists which are more stringent than Certification Bodies audit checklists and helps companies pass MDSAP certification audits with minimum nonconformities or no nonconformity
- 98% of QSE assisted facilities passed the initial MDSAP certification audit with zero deficiencies with a 100% passing rate first time around
- QSE covers all the requirements of the MDSAP standard including the implicit intent of the MDSAP standard
- QSE develops MDSAP quality management system involving all relevant employees which lead to effective implementation of MDSAP standard
- QSE provides is unique comprehensive single level simplified documentation to ensure effective implementation of MDSAO standard
- QSE’s MDSAP documentation is unique, simple, lean and easy to implement and sustains certification audits in the long run
- QSE ensures to provide implementation assistance or complete understanding of the documentation and MDSAP requirements
- QSE’s unique management review format results in to no nonconformities against management review during certification audits.
- QSE does not simply tell our customers what to do but assists them on how to do
- QSE’s 10-step disciplined path for MDSAP certification achieves organizations certification in the shortest possible time. Usually within 5 months
- QSE provides post MDSAP Certification auditing services, if required, and can take the disputes to the highest levels for resolution
- Basically, this standard is meant to have a comprehensive approach of auditing manufacturers of medical devices for quality management systems and regulatory requirements. This standard is an effort by Food and Drugs Authority of USA (FDA) to reduce regulatory inspection visits to companies making medical devices. This single MDSAP certification audit instead of duplicating with an MDSAP audit and another with regulatory audit.
- From 01 January 2014 to 31 December 2016, FDA, alongside its international partners, participated in a Medical Device Single Audit Program Pilot. On 29 June 2017, a report was generated based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined that the MDSAP Pilot had satisfactorily demonstrated the viability of the Medical Device Single Audit Program.
- FDA continues to accept MDSAP certification audit reports as a substitute for routine Agency inspections.
- Firms with activities related to the Electronic Product Radiation Control (EPRC) provisions of the Act continues to be subject to FDA inspections for the EPRC activities
- The benefit to medical device manufacturers is that they can avoid regulatory inspections by having MDSAP certification, for their organization valid in 6 other countries other than the USA
The Audit Sequence of MDSAP focusses on 4 Main Processes but the audit digresses to other related processes also:
2) Measurement, Analysis, and Improvement
3) Design and Development
4) Production and Service Controls
The second Focus item in MDSAP Audit is the audit on supplementary processes listed below:
- Device Marketing Authorization and Facility Registration
- Medical Device Events and Advisory Notices Reporting
The four areas where MDSAP auditors may inquire in depth would be:
- Risk activities as they relate to all processes
- Your outsourced processes
- Design and process validations
- Change management and associated risks
The MDSAP Auditing System
Please follow the link to reach the details on MDSAP grading system:
For learning about MDSAP grading system document prepared by Global Harmonization Task Force
MDSAP does not involve in writing Major and minor nonconformities as practiced in ISO audits. MDSAP uses a matrix system of grading the direct impact of the medical device on the user and indirect impact of the medical device on the user. Grading is accorded on a scale of 1to 5 where 1 being the score where there is least impact. Scoring Lower is better grading for MDSAP audits. Those facilities which score high, gets time to come with action plan to reduce scores due to direct or indirect impact, submit verified results. Certification is accorded when the auditor is satisfied with verified results or re audit to verify impact results.
Another Important study material is the FDA document available for free on the FDA website is the MDSAP companion document which details the requirements for compliance to MDSAP. Follow the link given below.
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Frequently Asked Questions
At present FDA, has not issued guidelines to have this certificate as Mandatory. It is only Voluntary. However, mentions that FDA will accept MDSAP certificate and will not have Mandatory Regulation Inspections once a company is certified to this standard.
MDSAP audit includes auditing of all requirements for MDSAP 13485:2016 in addition to consolidated regulatory requirements of participating countries. Companies have an option to get this one single audit or get MDSAP audit and regulatory inspections.
This standard is applicable to Medical devices to Class II and above. Manufacturers of medical devices to Class I without any human or animal contact need not have this certification
After March 31, 2016, MDSAP will be the primary means for a medical device manufacturer that markets its devices in the United States to participate in a Third-Party Audit program. Under MDSAP, the Food and Drug Administration (FDA) will accept MDSAP audit reports as a substitute for routine inspections.
“The content of medical device regulatory audit reports must satisfy requirements for: third-party Quality Management System (QMS) audit reporting for Conformity Assessment (Australia); supporting an application for, or maintenance of a device registration request (Brazil); the manufacturer Good Manufacturing Practice (GMP) conformity evaluation (Brazil); a medical device license (Canada); QMS Inspection Guideline (Japan), or, a third-party audit for the United States”.