For Medical Device Manufacturers | MedSec

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For Medical Device Manufacturers

Healthcare Cybersecurity Consulting

Build More Secure Devices

From Design Through Regulatory Approval

Our clients have developed noteworthy engineering to monitor patients ’ health, diagnose disease, and deliver lifesaving treatments. however, with every new medical device they create – which normally requires connectivity to enterprise networks and multiple software applications – they face a growing number of cyber threats .

That ’ s why many medical device manufacturers – from the most respected in our industry to startups – trust on MedSec during the development work to ensure the follow :

  • Greater speed to market
  • Fewer regulative delays
  • submission with international standards
  • Comprehensive regulative submission documentation
  • Pre-submission aid
  • support to address deficiencies and vulnerabilities
  • Enhanced maturity of risk management programs
  • continuous improvements to patient base hit

secure.jpg MedSec helps our clients design and build medical devices to resist cyberattacks and to prevent access to the vital networks healthcare pitch organizations operate .

furthermore, MedSec ’ s team of cybersecurity experts, which includes some of the industry ’ s most recognize authorities, provides guidance to ensure device manufacturers meet increasingly complex regulations imposed by the FDA and early regulative bodies throughout the world .
​ More Than Just Ensuring Regulatory Compliance

At MedSec, we do more than ensure regulative conformity – we ensure that unique cybersecurity risks are immediately addressed. In accession to adapting device regulations from the International Organization for Standardization ( ISO ), the European Union, and countries that have adopted the Medical Device Single Audit Program ( MDSAP ), MedSec is part of the team leading the charge to guide regulative measures. Partner With MedSec, A Little Or A Lot

At MedSec, we recognize that every manufacturer has different internal resources. That ’ south why we structure our consulting engagements to meet your needs. Hire us for a deep prima donna into a major product line or class, or engage our experts on a project-by-project basis…whatever works best for your organization .

We offer a continuum of consulting services so you can access precisely what you need, including :medscan-icon-security.png Product Security Programs – build and integrate The MedSec team is ready to review and aid in the integration of processes and procedures to ensure that your product security program is compliant – whether it is brand-new or a retool of an existing course of study. We can besides help make your product security programs part of your overall quality system flow .

The MedSec team is well familiar with industry-leading documents, such as AAMI TIR 57 for security risk management, AAMI TIR 97 for postmarket security risk management, IEC 80001-2-2 for security capabilities, IEC 62443, ISO/IEC 15408, UL 2900, NIST SP 800-53, NIST RMF, and FIPS-140-2 and 140-3 .

MedSec is fix to assist in the execution of every aspect of your intersection security program, including :

  • Product Security Programs, including : ​​

    • Product Security Incident Response Program
    • Vulnerability Monitoring and Management Process
    • Patch Management Process
    • Product Security Baseline Design Requirements
    • secure Development Lifecycle
  • Coordinated Vulnerability Disclosure
  • Cybersecurity Risk Management
  • Cybersecurity Risk Assessment
  • penetration Testing
  • System Design And Architecture Review
  • Regulatory conformity
  • Strategic Planning
  • train

Cybersecurity Risk Management You can not secure what you don ’ deoxythymidine monophosphate know you have. The foundation to a successful medical device cybersecurity program is knowing what aesculapian devices you have, where they are, what they are doing, and whether they need cybersecurity attention. MedSec offers services and solutions to tackle this singular and fundamental challenge .
​ Coordinated vulnerability disclosure ( CVD ) is used by every diligence, in which a security research worker agrees to coordinate the disclosure of the vulnerability with the manufacturer, typically after a fix has been developed .

Having a process for coordinated vulnerability disclosure helps manage the business gamble of having researchers find vulnerabilities in your products. In addition, the FDA besides offers incentives to companies with full-bodied disclosure and patch management programs for managing qualify vulnerabilities and reducing regulative load. MedSec assists in construction or fortifying your coordinated vulnerability disclosure course of study, arsenic well as ensuring you take advantage of the incentives available from FDA to reduce your postmarket regulative load when patch .

Product Security Incident Response Program Cybersecurity attacks on aesculapian devices and healthcare critical infrastructure are occurring more frequently. Incident response is a term used to describe the march by which an organization handles a cybersecurity attack, ensuring that teams respond cursorily and seamlessly to an incident. MedSec can assist in respective ways, including helping human body or mature a product security incident reaction program, adenine well as running tabletop exercises where teams assemble and exercise their process. tabletop exercises are critical to an efficient and reactive team. Vulnerability monitor and management presents a new challenge to medical device manufacturers. medical device manufacturers are expected to monitor their products, including third-party software components, for new vulnerabilities after they are placed on the marketplace .

Any new vulnerabilities must be managed to determine if patch is required, and if so, how urgently. MedSec assists in the development of this process and its integration into the larger Quality System .
​ Software patch is not new for aesculapian device manufacturers. however, security patches can create an increase burden due to the tempo and frequency of the patch serve when efficaciously managing security vulnerabilities .

Both hospitals and regulators are putting pressure on checkup device manufacturers to patch promptly and frequently to protect the healthcare critical infrastructure. This can put coerce on manufacturers who built their bandage management programs years, if not decades, earlier .

MedSec can help you update your while management summons to meet customer and regulative expectations .
​ A common question in security is : “ How much security is enough security ? ” A big way to address this write out is to develop a sic of baseline security requirements that work for your products and organization. These baseline design requirements are typically established based on industry best practices, standards, and regulative requirements .

MedSec staff have deep technical cognition in this area and can help you navigate the often-confusing worldly concern of coding standards and conformity expectations. This is much not a one-size-fits-all situation, and we can help you find the arrant fit .
​ Adding security in the blueprint march is more cost-efficient and successful than adding it as an reconsideration. MedSec specializes in the security of aesculapian devices and can help you tax and mature your existing process to keep development costs and timelines in check .

however, security does not stop when the merchandise is released to market. Part of lifecycle management is maintaining that security position throughout the defined life of the medical device. This involves consistent vulnerability monitoring, postmarket risk management, piece, and incident response .

MedSec can help you connect security elements and ensure that they are integrated into the larger quality system, streamlined, and effective .
medscan-icon-fda.png Cybersecurity Risk Assessment Meet FDA and other ball-shaped premarket cybersecurity guidance documents by conducting a cybersecurity hazard assessment with MedSec. Cybersecurity risk assessments are an have a bun in the oven depart of an FDA 510k and PMA. MedSec uses the industry leading AAMI TIR 57 methodology to develop a full cybersecurity risk assessment ready for an FDA or ball-shaped file .medscan-icon-penetration.png penetration Testing The MedSec team can perform vulnerability and penetration testing on your medical device or medical device ecosystem. Because MedSec specializes in aesculapian devices, we understand the unique regulative environment, operating environment, and consumption cases .medscan-icon-systemdesign.png System Design And Architecture Review Catching cybersecurity weakness at the plan phase of a intersection lifecycle is typically the least impactful to the overall plan lifecycle. Our cybersecurity experts will review design and computer architecture documentation to identify potential areas of helplessness and aid in design genesis for securing fallible areas .medscan-icon-regulatory.png Regulatory submission Our experts have extensive know driving positive cybersecurity policy changes through versatile activities with the FDA. In accession, they remain dedicate to enhancing their fat relationship between regulative agencies and diligence. The MedSec team can assist in navigating the medical device regulative environment for cybersecurity and software issues through reference and strategic plan .

Let us help you reduce the likelihood of impacts on intersection delivery timelines due to unexpected regulative delays through aid with :

  • Global regulative complaisance in cybersecurity and software
  • global regulative submission activities, including :

    • Creation and/or review of cybersecurity and software section content
    • documentation for responses to deficiency letters involving cybersecurity and software issues
  • Product classification, particularly with digital health products and raw twenty-first Century Cures Act guidance in the U.S .
  • Regulatory scheme for designing and managing connected and software-driven devices, considering new guidelines from the U.S. FDA, European Union, Asia, Australia, and Canada
  • support for cybersecurity and software-related issues at FDA meetings and engagements ( onsite and behind-the-scenes ), including pre-submission meetings

medscan-icon-strategic.png Strategic Planning For Device Design And Classification Regulators from across the globe are releasing raw steering and requirements in cybersecurity and software. The MedSec team can assist in regulative strategies and achieve the best balance between invention and conformity. We can assist with key guidance interpretations for external reputations, documents, and directives, american samoa well as classifying your digital health devices. In addition, we can aid in work improvements and efficiencies that can be implemented across your timbre system .medscan-icon-training.png educate The MedSec team is comprised of industry experts who stay involved in ever-evolving cybersecurity trends. Allow us to bring that cognition to your teams in custom-make train to ensure your team is informed and engaged in new expectations and steering. Our trail will include current and emerging expectations from across the globe to ensure that you are disposed for nowadays and are planning for the future .

Topics include :

  • terror Modeling — how to create, leverage, and integrate a threat modeling practice into your safety and security gamble management process

  • Cybersecurity Compliance — updates on global cybersecurity steering in key markets such as the U.S., Europe, Australia, Canada, and Asia

  • Standards — outline and manipulation of domestic and international cybersecurity and software standards, plus a inspection of approaching cybersecurity and software standards

  • Digital Health Strategy — make the most of recent guidance on SaMD and emerging technology

  • Tabletop Exercises — pressure-test your merchandise security system plan with incidental simulations to ensure set for the following ball-shaped event

  • Secure Design Lifecycle — integrate cybersecurity into your product development lifecycle

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