United States: Your QMS Supports Your Global Operations And We Are Prepared To Support You

Our FDA compliance team has received ISO 13485 auditor certification

Satisfying ISO 134851 is important for U.S. and international medical device firms. Companies selling in the EU must operate their quality management systems (QMS) in compliance with applicable QMS requirements laid down in the relevant Medical Device Directives or the new Medical Device Regulations (EU MDR and EU IVDR) through meeting the requirements of ISO 13485. Companies selling in the United States must still comply with 21 C.F.R. Part 820, the Quality Systems Regulation (QSR), but the U.S. Food and Drug Administration (FDA) has indicated an intention to move toward harmonization with ISO 13485 as the compliance standard of choice. Additionally, FDA has joined Brazilian, Canadian, Australian, and Japanese regulators in participating in—and in some geographies mandating—audits conducted through the Medical Device Single Audit Program (MDSAP).

Our medical device lawyers and regulatory science professionals have extensive experience in designing and implementing robust quality management systems for medical device manufacturers. With our deep bench and extensive knowledge of your industry and regulators, we are uniquely positioned to help your company refine existing systems to align with evolving regulatory obligations while supporting your growing operations. We have helped hundreds of clients prepare for both domestic and international inspections, supported them during those inspections, and advised them on taking appropriate corrective and preventive action. All of this means that we can help you in these business critical areas: (1) implementing a QMS that is designed to improve your products and processes; (2) recognizing opportunities for improvement; and (3) taking remedial action to mitigate the potential for findings during a regulatory audit. We also regularly represent clients before regulators and notified bodies to find workable solutions to complex health, safety, quality, and regulatory matters.

Our experience and training puts us in a unique position to assist our clients with the challenges that face medical device companies of all sizes around the globe. Our team of compliance lawyers and regulatory science professionals has over 100 years combined experience working with medical device companies. To complement our extensive real-world, practical experience, our team of compliance lawyers has received ISO 13485 auditor certification and enhanced MDSAP training. We understand how the international standard and QSR interact, and we can help you plan and manage for the interplay of the two because we know you operate only one QMS.

Members of our team reside in the United States and Brussels, and understand medical device businesses and the priorities and initiatives of U.S. and EU regulators. In other critical geographies, we have lawyers ready to assist who have developed relationships with in-country legal counsel to help in the global markets where you operate.

Representative experience

  • Conducted numerous QMS (QSR and ISO 13485) audits both domestically and internationally to help companies make their processes more robust and to prepare them for inspections by regulators and audits by notified bodies
  • Assisted numerous companies in taking remedial actions related to FDA Warning Letters and 483 Notices of Observation, including situations that were considered by FDA to be of high public health importance.
  • Assisted clients in preparing robust 483 responses following inspections with significant findings for which FDA noted the strength of the response was instrumental in the agency's decision not to issue a Wanting Letter.
  • Evaluated quality systems and identified strategic opportunities to make improvements in advance of expected inspections.
  • Assisted various medical device clients in addressing the quality management system non-conformities identified by their notified bodies.
  • Prepared and built out a quality system tailored to the needs of a client entering the medical device space for the first time.
  • Attended numerous foreign inspections to help facilitate communication between our client and FDA and assist the client in managing the inspection.
  • Conducted third-party audits to certify to the FDA that our client had taken the necessary corrective actions to address FDA's inspectional observations.
  • Helped a company develop and monitor a corrective action plan designed to address systemic issues with the client's quality systems.
  • Prepared and supported an international client, by drafting their PMA manufacturing section and supporting them on site through their PMA inspection for their first product, resulting in no observations.
  • Drafted and negotiated numerous quality agreements, supply agreements and contract manufacturing agreements focusing on quality and regulatory issues.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions