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Regulatory Strategy and Planning

Navigate Regulatory Challenges for Seamless Product Launches

Companies often do not have the internal capacity or expertise to handle all aspects of regulatory affairs simultaneously. At AlvaMed, we balance regulatory risk with your business goals to provide strategic direction on complex regulatory challenges across all major markets. With experience in orthopedic, cardiovascular, SaMD, and therapeutic devices, we develop a plan for you to meet evolving regulations and standards and accelerate your product launch.

Define your product technology, accounting for any novel characteristics with a focus on the intended use.

Define the worldwide markets that are of most interest to support product adoption.

Review the device classifications for each chosen market to define the regulatory pathway.

Review currently available devices that validate the regulatory pathway and testing and/or clinical requirements. Create a summary of the information as a roadmap for gaining regulatory approval.

Based upon the strategic roadmap, develop a detailed plan for gaining regulatory approval.

AlvaMed has successfully supported the launch of medical devices in a multitude of global markets.

We were working on a very tight deadline to submit 483 responses to the FDA with extremely limited resources to get the job done. We hired AlvaMed to help us, and they were able to on-board, advise us on strategy, work with our team, and draft responses to our findings in less than 2 weeks. Before bringing the AlvaMed team on, we worried this would not be an achievable task. We were thrilled with the outcomes and our team gained an incredible amount of knowledge in working with AlvaMed’s experts. I would highly recommend AlvaMed to any company requiring QA/RA support.

Directory of Quality

International Med-Tech Company

A small medical device company facing limited resources successfully updated their QMS and achieved MDR compliance with AlvaMed’s expert guidance and efficient tools.

MDR Compliance

CASE STUDY

We want to acknowledge the exceptional regulatory support provided by AlvaMed, particularly in our 510(k) submission process. AlvaMed’s expert guidance, meticulous attention to detail, and unwavering commitment to compliance were pivotal in securing the successful clearance of our medical device. Their knowledge and dedication streamlined what could have been a daunting process, and we are incredibly grateful for their partnership. We highly recommend AlvaMed to anyone seeking top-notch regulatory support in the medical device industry.

Jeff Cyr

We want to express our sincere appreciation for AlvaMed’s outstanding support throughout our MDSAP and CAPA project. With AlvaMed by our side, we not only achieved regulatory adherence but also fortified our quality management systems. AlvaMed’s partnership has been transformative, and we recommend their services to anyone seeking a smooth pathway through the medical device regulatory requirements.

Mira Leiwant

Client feedback rated AlvaMed’s work excellent and the results enabled the client to: Have the justification to go to the parent company’s management and request additional funding to accelerate two highly attractive technologies, maintain development funding for two other technologies, shelve the remaining technology.

Regulatory Strategy

CASE STUDY

AlvaMed is a great partner for a small company like ours. Their invaluable support, including quality assurance consulting services at various levels in the organization have supported our Director of QA/RA without the need to hire additional people. Their expertise in bringing companies into compliance with the EU MDR and supporting notified body audits, has been vital in helping us navigate the complexities of our industry. We highly recommend AlvaMed to any company looking for a reliable and supportive partner.

Director of QA/RA

Endosurgical Device Company

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

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We look forward to discussing AlvaMed’s services with you.

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Regulatory Strategy and Planning FAQ's

Regulatory requirements vary depending on the type and intended use of the medical device. Generally, key aspects include:

  • Classification: Understanding how the device is classified (Class I, II, or III).
  • Quality Management Systems (QMS): Implementing a QMS compliant with relevant standards (ISO 13485).
  • Labeling and Documentation: Ensuring accurate and compliant labeling and preparing essential documentation.

Navigating the regulatory pathway involves:

  • Device Classification: Determining the device class based on risk and intended use.
  • Regulatory Submissions: Identifying the appropriate submission type (e.g., 510(k), PMA, CE Marking) and preparing the necessary documentation.
  • Engaging with Regulatory Agencies: Establishing communication with regulatory authorities for guidance and clarification.

Essential documentation includes:

  • Technical Documentation: Comprehensive details about the device design, manufacturing, and performance.
  • Clinical Data: Data from clinical studies supporting the device’s safety and efficacy.
  • Quality Management System Documentation: Ensuring compliance with ISO 13485 and other relevant standards.
  • Risk Management Documentation: Identifying and mitigating potential risks associated with the device.

Eric Bannon

Senior Vice President

Eric has extensive experience in the start-up company environment to offer clients the strategic guidance to create an effective regulatory plan to guide interactions and submissions.

Schedule a meeting with Eric to discuss how AlvaMed can optimize your regulatory and strategy planning. 

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  • Office: 1116 Great Plain Ave, Suite 105 • Needham, MA 02492
  • Mailbox: 935 Great Plain Ave, Suite 166 • Needham, MA 02492
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