Category Archives: Medical Device Tracking

Thie category contains all the Medical Device Tracking Posts

Tracking Medical Devices – MedDevTrack Webinar

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Thursday, November 17, 2016, at 11am PST / 2pm EST

Register Now!

 

MedDevTrack is unique in the medical device industry as it provides an end-to-end solution for device tracking – beginning from the end of manufacturing through all phases of distribution, clinical use and patient tracking. It features a workflow engine that allows you to configure the software to match your SOPs and provides a self-auditing record for compliance to your own SOPs and those imposed by regulatory agencies.

Providing a comprehensive, integrated Medical Device Tracking solution for all your stakeholders:

  • Procurement/Distribution
  • Regulatory/Quality Assurance
  • Information Technology
  • Medical/Clinical
  • Post-Marketing/Surveillance

Thursday, November 17, 2016, at 11am PST / 2pm EST

This webinar is part of our continuing Medical Device Tracking Symposium Series by leading industry experts working with solutions for medical device tracking and regulatory compliance. We want to bring you much more accurate information than you can find through internet searches – real, actionable tips from the people who are constantly refining their knowledge to provide a great forum for sharing critical information and updates.

Portford Announces MedDevTrack – The Next Generation for Medical Device Tracking

MedDevTrack

Portford Solutions Group announces the release of MedDevTrack, our second generation of proven software for medical device tracking offering full compliance to mandated FDA regulatory requirements.  Covering all classes of medical devices, this FDA Unique Device Identification (UDI) compliant enterprise application is based on Portford’s agile-based development strategy and implementation for their best-in-class SaaS solution.

We would like to introduce our new website for device tracking at MedDevTrack.com.  The site provides more detailed information and discussion about the software, service and educational offerings in support of our second generation software release.  We have brought aboard a group of renowned industry experts to help aid in the successful configuration and implementation of our device tracking solution to meet all your regulatory and operational needs.  More information related to this news can be found at the following link http://www.meddevtrack.com/meddevtrack-medical-device-tracking-manufacturing-clinical-use/

Webinar: Tracking Medical Devices – How to Manage UDI Compliance Readiness

Location and Date: Orange County, CA – 4 November 2015, 11:00am-11:40am PST – Portford Solutions Group

Portford Solutions Nick & Bruce Bolton and Axcent Advanced Analytics Joe Buonomo to co-host an online event about how the rapidly changing FDA regulatory requirements affecting medical device tracking will be accommodated by Portford Solutions’ agile-based development strategy and implementation for their best-in-class SaaS solution.

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The first in a series of Webinars to be held on November 4, 2015 to discuss the important regulatory requirement of coming into compliance for with the new FDA regulation for Unique Medical Device Identifier requirements. Portford Solutions will be sponsoring this first in a new Symposium series and will discuss how their current offering complies with the beginning of the FDA requirements for device tracking. Central to this offering is the creation of a Software as a Service (SaaS) platform, a cloud-based solution that is a best-in-class model for both its cost-effectiveness and ease of deployment to solve a wide range of medical device business challenges.

Portford Solutions Group is sponsoring this program, presented by two of its founders: Bruce Bolton, Executive VP – Technology and Nick Bolton, Executive VP – Consulting; Axcent Advance Analytics Joe Buonomo, CEO and VP, Business Solutions, a long-standing expert in FDA regulation and guidance and its application within the Medical Device industry.

The Medical Device Tracking Symposium Series will be covering many topics throughout this coming year related to changing government regulations, industry guidance, infrastructure and technological challenges facing us all in this industry. The Symposium series will be a prime source for many white papers, webinars, blogs and a conference on this topic and will be available from the MedDevTrack.com website, a premier site for information and access to best-in-class software serving the industry.

We Will Be Discussing:
  • What is the September 2013 FDA Final Rule on UDIs for medical devices and what does it mean for our industry?
  • What exactly is the Law (regulation) and what isn’t?
  • What are our timelines for compliance by device class and what are the expectations for compliance?
  • Anything under considerations that may affect this changing regulatory environment?
  • How can MedDevTrack and Portford Solutions help me with my compliance needs?
  • What is MedDevTrack and Portford Solutions’ plan to meet or exceed compliance requirements with their solutions?
  • Are there any publications available that I can take with me after the presentation to help further understand all of this in a deeper way?
Register Now!

The webinar is taking place on Wednesday 4 November 2015, 11:00 am- 11:40 am PST and attendance is free for this valuable presentation. Register now by clicking on the following URL: http://www.meddevtrack.com/registration.html.

Medical Device Tracking: Rapidly Changing USA and Worldwide Regulatory Environment

The September 2013 FDA Final Rule on UDIs for medical devices is now law!

 

So what does this mean for Medical Device industry?
It means that imminently, medical device manufacturers will have to upgrade their labeling and packaging systems along with their data management capabilities in order to stay compliant with incoming regulations and this is independent of creating systems to meet the demands of electronic regulatory reporting to the FDA and EMHA agencies.
How can Portford Solutions help me with my compliance needs?

On the whole, there was little concentrated information on the state of devices provided to the patient population by the industry. Simple marketing data such as what company makes what device; sales figures of each individual implants per medical device companies; or the number of procedures done for each implant each year are readily available. Key safety and efficacy information is not readily available to the companies, regulatory agencies and the communities they serve. Industry watchdogs are concerned that little information is gathered in any one place about the potential dangers and flaws of these devices, or the complications that occur due to their implantation procedure. Revised regulations are forthcoming, to be implemented over time.

At Portford, our stated systems development direction for both core software and services will fill this shortcoming by providing all the requirements for medical device tracking, patient clinical data collection and regulatory reporting. In addition we will be offering advanced data analytics and predictive analysis integrated into our workflow-based medical device tracking software to report on trends in device stability, performance and providing early detection of problems with devices before they become an issue for the companies, regulatory agencies and the patient population.

Continue reading Medical Device Tracking: Rapidly Changing USA and Worldwide Regulatory Environment

Medical Device Tracking – The Next Generation

Our Commitment for Best-in-Class Medical Device Management Solutions

To complement our strong expertise in Medical Device Tracking workflow development, we have been actively working to enhance our whole collection of software and service offerings to meet the rapidly changing regulatory environment facing the device industry. One of the greatest obstacles and concerns for the industry is the nascent and coming regulatory changes (1) being imposed upon the industry; the larger the company, the greater this burden is reported. In addition, there is always a core goal for providing health outcomes that meet the best practice that can be delivered for the medical community – Is what we manufacture and aid in the delivery to patients, safe and effective?

At Portford, our stated systems development direction for both core software and services will fill this shortcoming by providing all the requirements for medical device tracking, patient clinical data collection and regulatory reporting. In addition we will be offering advanced data analytics and predictive analysis integrated into our workflow-based medical device tracking software to report on trends in device stability, performance and providing early detection

of problems with devices before they become an issue for the companies, regulatory agencies and the patient population. From a recently published report (2) it has been determined that the 510(k) program is in need of modification to support both patient safety and efficacy concerns.

Continue reading Medical Device Tracking – The Next Generation

Outsourced Device Tracking – 21 CFR Part 821

Portford Solutions Introduces DocuNECT for Device Tracking

Medical Device manufacturers are required by the FDA to track certain types of devices from manufacture through the distribution chain. The FDA released 21 CFR Part 821, which governs the requirements around the tracking process.

In response, Portford has developed DocuNECT, a web-based Device Tracking solution that is available in two ways:

  • On-Site: Software implemented behind your firewall
  • Hosted: A SaaS model where you can pay monthly

In addition, Portford also offers a complete managed service that combines the SaaS model with our call-center of trained device tracking specialists that will manage the entire process. Our services begin with fully documented policies and procedures that aid with FDA compliance.

Each client is allowed to customize the workflow to meet the profile of your device or specific needs. The operations team then follows these policies and procedures and conduct regular audits to verify compliance. We have a wide variety of reports and reporting methods which employ industry standards and tools.

Click here to save the January 27, 2011 WebEx meeting in your Outlook Calendar or contact: info@portfordsolutions.com for more information about new product features or join us for a WebEx demonstration on January 27, 2011 at 10:15 am PST.

What Devices Need Tracking
The FDA mandates organizations to track the following medical devices:

  • Glenoid Fossa Prosthesis
  • Mandibular Condyle prosthesis
  • Temporomandibular Joint (TMJ) Prosthesis
  • Abdominal Aortic Aneurysm Stent Grafts
  • Automatic Implantable Cardioverter / Defibrillator
  • Cardiovascular Permanent Implantable Pacemaker Electrode
  • Implantable Pacemaker Pulse Generator
  • Replacement Heart Valve (Mechanical only)
  • Implanted Cerebellar Stimulator
  • Implanted Diaphragmatic / Phrenic Nerve Stimulator
  • Implantable Infusion Pumps
  • Silicone Gel-Filled Breast Implants
  • Cultured Epidermal Autografts

Customer Challenges
The FDA released 21 CFR Part 821, which governs the requirements around the tracking process. The regulations were released in August, 1993 which has allowed a number of companies to become familiar with the regulation of data that needs to be collected and the follow-up processes that are required to insure reasonable attempts to obtain the data.

In practical terms managing Device Tracking comes with its own set of challenges. They include:
FDA Regulatory / Compliance

  • Risk Due to Lost Data
  • Inconsistent Follow Up

Multiple Systems and Technologies

  • Located in Many Locations
  • Incompatible Formats
  • Lack of Technical Resources

No Consistent Protocols and Processes

  • Lack of Information Control
  • Privacy Concerns
  • Require Heavy Customization

Lack of Reporting Tools

  • No Strategic Dashboard
  • Obsolete Reports
  • Lack of Audit Trail

Labor Intensive

  • Overly Manual Intervention Required
  • Lack of Facility Space
  • Lack of Audit Trail to Focus on Core Competency

How do you feel your organization measures up when it comes to efficiencies gained through outsourcing your Device Tracking? Contact Portford today to discuss best practices in your industry and identify how your business processes can be improved.

DocuNECT Features
DocuNECT is a robust and versatile option for your Device Tracking needs. Our services begin with fully documented policies and procedures that aid with FDA compliance!

Each client is allowed to customize the workflow to meet the profile of your device or specific needs. The operations team then follows these policies and procedures and conduct regular audits to verify compliance.

Benefits of DocuNECT for Device Tracking include:

  • Facilitates FDA Compliance
  • Proven Validated System

One Centralized System

  • One Hosted Location
  • On-line Access 24/7/365
  • Dedicated Technical Staff

Validated System Designed Specifically for Medical Device Tracking

  • Automated Workflow Ensures Consistent Patient Data Follow-Up Process
  • Compliant Solution 21 CFR Part 11 Electronic Signatures Enabled
  • Patient Data Management According to HIPAA Guidelines
    Managed Tools Include
  • Management Dashboard
  • Real Time Reporting
  • Audit and Reconciliation

Managed Workflow Include

  • Automated Faxing In / Out
  • Predetermined Review and Escalation
  • Dedicated Scanning and Indexing Center

Contact info@portfordsolutions.comto learn more about DocuNECT for Device Tracking.