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MDSAP is a standardized global auditing program which allows for a single regulatory audit of a medical device manufacturer’s quality management system (QMS) to be conducted to satisfy the requirements of several global regulatory agencies and/or regulatory bodies. 

MDSAP was conceived in 2012 (launched in 2014) by the International Medical Device Regulators Forum (IMDRF).  The program officially completed the pilot phase in December of 2016 and manufacturers are now able to begin the process for certification.  Currently 5 countries are participating in the program and they include: USA, Canada, Australia, Brazil and Japan.  The World Health Organization (WHO) and the European Union (EU) are Official Observers.  One special area of consideration is that manufacturers selling products in Canada have a deadline of January 1, 2019 to become certified in order to continue to sell their products on the Canadian Market. MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) in Canada. The two (2) year transition period in Canada started on January 1, 2017 and continues through January 1, 2019. At the end of this transition period, only MDSAP certificates will be accepted. 

 

Global Regulatory Authorities Designated Use of the MDSAP Audit Reports
US – FDA	The FDA will accept the MDSAP Audit Report in lieu of FDA routine inspections.However, MDSAP does NOT apply for certain types of regulatory inspections including:·         “for cause” inspections·         “compliance follow-up” inspections; or·         pre-or post-approval inspections for PMA (Premarket Authorization)
Canada – HC	MDSAP will replace the Canadian Medical Device Conformity Assessment System (CMDCAS) by the end of the (2) two year transition period in Canada [January 1, 2017 to January 1, 2019]. After the transition period ends in Canada, only  MDSAP certificates will be accepted.
Australia – TGA	MDSAP Audit Reports may be used to support compliance with the medical device authorization requirements (unless the particular medical device is excluded or exempt from the requirements)
Brazil – ANVISA	MDSAP Audit Reports may be used to support the technical evaluation of the premarket and post-marketing requirements.
Japan – MHLW and PMDA	MDSAP Audit Reports may be used to support the premarket and postmarket requirements.

 

MDSAP audits must be conducted by recognized Auditing Organizations (AO) authorized by the participating global regulatory agencies and/or regulatory bodies pursuant to the MDSAP requirements.  These will be conducted on an annual basis based on a (3) three year certification cycle.

 

What to expect in the MDSAP audit:

During your MDSAP audit, you should expect the Auditing Organization to cover all elements of ISO 13485 (Management, Device Marketing Authorization, Measurement and Analysis, Medical Device Adverse Events Reporting, Design and Development, Production and Service Controls, and Purchasing) with a heavy emphasis on:

• Incorporation of risk within all processes to manage your product lifecycle
• More scrutiny on your outsourcing practices
• Both design and process validation
• Design change management and risks associated with these changes

 

Value Proposition

Traditionally, manufacturers selling their products globally were faced with the challenge of being audited by multiple regulatory authorities causing disruption to manufacturers.  MDSAP evolved because it was recognized that a single audit would be more efficient while ensuring the Quality Management System was thoroughly covered during an audit.  It also provides consistency in the audit process and minimizes the burden on resources.  All important factors when you consider efficiency goals within an organization.

 

What’s in it for the Regulatory Authorities?

• Creates a coalition of countries utilizing shared technology, resources, and services to improve the oversight of medical devices more efficiently.
• Better utilizes the widely accepted international standards and best practices to achieve alignment of regulatory approaches of multiple regulatory bodies.

 

What’s in it for the manufacturer?

• One audit overall instead of one per Regulatory Authority means less burden on manufacturer resources to deal with multiple audits.
• Use of standardized non-conformity grading system will make the outcomes more predictable.
• Utilization of a consistent audit criteria compliant to the requirements of all participating regulatory authorities will be used by the Auditing Organizations.
• Saves you time and money by participating in 1 audit versus multiple audits.

 

Country specific Adverse Event Reporting

• In 2012 Australia made access available to the Database of Adverse Event Notifications (DAEN). The database is searchable by report number, date, manufacture, sponsor, etc. 
• The Manufacturer and User Facility Device Experience (MAUDE) has been available since 1996 and is also searchable by report number, date, manufacturer, etc. The product problems are categorized into more than 1,000 device and patient problems as defined by Code 3500A
• Canada utilizes what is referred to as the Adverse Reaction Database. The search criteria is more limited however, reports date back to 1965.
• Japan and Brazil also have information available publicly however, the incidents are only available in the local languages.
• European Database on Medical Devices (EUDAMED)*
  • EUDAMED will be an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission’s Enterprise and Industry Directorate General and the Competent Authorities in the European Union Member States. Its legal basis is laid down in Directives 90/385/EEC, 93/42/EEC, 98/79/EC and 2000/70/EC.
  • EUDAMED will also develop a vigilance module. This vigilance module will inform Member States on incidents or near-incidents in relation to certain devices on the market.
  • EUDAMED will also develop a vigilance module. This vigilance module will inform Member States on incidents or near-incidents in relation to certain devices on the market.

*Note, EUDAMED is expected to be operational in March of 2019.  Note this date is subject to change.

 

About RCA’s Medical Device Consulting Services

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post-market compliance throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA’s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

Our team of over 500 industry experts — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans, or consent decrees. We offer expertise in a variety of medical fields, such

 

Cybersecurity

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates Inc.®, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks.

With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and/or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

As a trusted regulatory affairs consultant, our FDA veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

• New Product Approval
• Post-Approval Support
• Outsourced Staffing
• EU MDR

 

Compliance Assurance

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates can help.

Our network of over 500 FDA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

• Gap Assessments
• Internal Audits
• Employee Training
• Notified Body Response

 

Quality Assurance

Regulatory Compliance Associates Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.

With more than 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and FDA veterans is fully equipped to handle your unique QA needs.

• ISO13485 
• 21 CFR 210
• 21 CFR 211
• Outsourced Staffing
• MDSAP
• Facility Validation
• Equipment Validation

 

Remediation Support

Regulatory Compliance Associates is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with RCA^® a competitive differentiator in the remediation space.

• Quality System
• Technical File
• Design History File
• Data Integrity
• cGMP 

 

Strategic Consulting

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates worldwide experience can help ensure a successful mix of people and products so your project is on time, on budget, and you’re never embroiled in a costly mistake.

Our 500 industry and FDA experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

• Manufacturing Optimization
• Product Lifecycle Management
• Mergers & Acquisitions (M&A)
• Due Diligence
• Device Vigilance
• Product Complaints
• Medical Information

 

About RCA^®

 

Regulatory Compliance Associates (RCA) provides medical device consulting to the following industries for the resolution of life science challenges:

 

• Life Sciences
• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

 

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.

 

 

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