02

Oct

2018

Manufacturers Assistance and Technical Training Branch (MATTB)

0

Email: Industry.Biologics@fda.hhs.gov
Phone: 240-402-8020 or 1-800-835-4709

After hours (after 4:30 pm EST weekdays, all day on weekends, and federal holidays)
FDA Emergency Call Center, Phone: 866-300-4374 or 301-796-8240

What The MATTB Does
CBER’s Manufacturers Assistance and Technical Training Branch (MATTB) responds to public inquiries for information (by phone and email) from the biologics industry. MATTB strives to provide timely, accurate and useful information to stakeholders.

How MATTB Can Help You
If you have a question about a biologics topic, MATTP may be able to help you. They try to respond to email within 5 business days.

If your inquiry is related to a regulatory submission that has been received by CBER, questions should be directed to the Regulatory Project Manager (RPM) assigned to that submission.

SoftwareCPR® can often provide timely advice that can optimize our clients’ interactions with FDA. If you would like to discuss your question with one of our partners, please give us a call at +1-781-721-2921 or leave a message below:

[contact-form to=”office@softwarecpr.com” subject=”MATTB Question”][contact-field label=”Name” type=”name” required=”1″ /][contact-field label=”Email” type=”email” required=”1″ /][contact-field label=”Website” type=”url” /][contact-field label=”Comment” type=”textarea” required=”1″ /][contact-field label=”Telephone” type=”text” /][/contact-form]

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

Agile principles that align well with medical
Backlog management
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

Americas: 11-13 February 2025
EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
Southern Central Northeastern Pacific: 24-26 February 2025

See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering: June 24-26, 2025 (Boston, MA)

Special pre-registration discount through January 31, 2025

Private, in-house courses can be scheduled. Contact us.

Email training@softwarecpr.com for more info.

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering: TBD