Library

  • All
  • Fact Sheet
  • News & Events
  • Press Release
  • Video
  • White Paper

News & Events


Upcoming Events in May & June 2017

The BBA team will be attending and presented at several events this spring. EuroPCR – May 16-19, Paris France Arena Outsourcing in Clinical Trials – May 23-24, King of Prussia, PA BBA Podium Presentation: New Study New Challenges: The Power of a…

News & Events


Dr. Joe Massaro to Present at Interim Analysis Symposium

Marlborough, MA – Joe Massaro, PhD, Senior Consultant, BioStatistics at BBA, will present on the topic of Data Monitoring Committees (DMC or DSMB) during his talk titled, “Design and Operate a High-Performing Data Monitoring Committee to Better Assess Trial Outcomes.”  In addition…

White Paper


New FDA Guidance for Medical Device Reporting for Manufacturers

On November 8, 2016, the FDA issued the long awaited final guidance, “Medical Device Reporting for Manufacturers.”  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm359566.pdf  The final guidance addresses medical device reporting and recordkeeping requirements for device-related adverse events and certain types of device malfunctions.  The guidance supersedes the…

White Paper


Boston Biomedical Associates Announces FDA eCopy Services

The FDA’s eCopy requirements for medical device regulatory submission has presented a plethora of new challenges and pitfalls for manufacturers who are trying to navigate the FDA’s regulatory process. If a company is not experienced with the process and requirements, a submission…

White Paper


What is an ICER and Why Should You Care?

The healthcare environment is changing rapidly and at all levels.  Value used to be defined as the number of procedures, products, or patients.  That is no longer the case and the challenge is therefore to define value, particularly where there are existing…

Fact Sheet


CDRH Modular PMA Alert – Process Changes

The FDA’s Center for Device and Radiological Health (CDRH) has issued a memo to modular PMA Holders regarding the implementation of PMA process changes that went into effect on June 13, 2016. The memo addresses how incoming Modular PMA submissions will be…

News & Events


Upcoming Events in May & June

May 26, 2016 Lauren Baker, PhD, President and CEO of Boston Biomedical Associates, will present a talk on US FDA regulatory issues for individuals in the medical device and biotech industry.  Her presentation, “Current Regulatory Trends at the CDRH and the CBER…

White Paper


Changes to Medical Device Regulations in China

The Chinese medical device market and regulatory landscape has undergone a myriad of changes in the past few years. China’s Medical device requirements have been extensively revised; in 2013, the Chinese Food and Drug Administration (CFDA) released 107 new medical device standards….

News & Events


BBA Announces Sponsorship of Medical Development Group

April 10, 2016 BBA is proud to sponsor the Medical Development Group (http://www.mdgboston.org).  The MDG is a community of professionals committed to advancement in the Medical Device and Medical Technology Industries.  Their mission “to contribute to the continuing development of medical devices…

White Paper


Environmental and Social Considerations for Medical Devices

In recent years regulators and law makers have given increased attention to ensuring that manufacturers of products sold in the United States, EU, and worldwide are socially and environmentally responsible. In this discussion, the Restriction of Hazardous Substances (RoHS) Directive and The…

White Paper


The New World of CER/CRBA Review

Recent experience has suggested that notified bodies are becoming more critical in their review of clinical evaluation reports (CER) or clinical risk/benefit analyses (CRBA).  The format “suggested” in MEDDEV 2.7.1 r3 is now the expected.  What does that mean to you?  It…

News & Events


Opal Medical Device Summit on February 9 and 10, 2016

Boston Biomedical Associates will be exhibiting at the Opal Medical Device Summit on February 9 and 10, 2016 in Boston. Stop by our booth to learn the latest on what BBA is doing to assist medical device companies manage the new EFS…

Fact Sheet


Regulatory Information or Regulatory Intelligence? What About ROI?

The following commentary explores the responsibilities of consultants and clients to achieve an effective partnership. A session at the 2015 RAPS’ Regulatory Convergence in Baltimore discussed the differences between regulatory information and regulatory intelligence. Which are you paying for when you hire…

News & Events


Transcatheter Cardiovascular Therapeutics (TCT) 2015

http://www.crf.org/tct Boston Biomedical Associates is pleased to announce that Lauren S. Baker, PhD, President and CEO will be participating in a Plenary Session at TCT in San Francisco on October 13, 2015 at 9:30 AM.  Dr. Baker will be a panelist for…

News & Events


AdvaMed Conference in San Diego on October 6 and 7, 2015

http://advamed2015.com Boston Biomedical Associates will be exhibiting at the AdvaMed Conference in San Diego on October 6 and 7, 2015. Stop by booth 230 to learn the latest on what BBA is doing to assist medical device companies manage the new EFS…

White Paper


The What, When, and How of Clinical Registries

Why a registry? Patient registries are an excellent data collection tool to use in today’s health care environment, particularly when there is a need to characterize or expand a patient population for a treatment, to develop new information which can be used…

News & Events


Boston Biomedical Associates Announces Senior Regulatory Appointment

Marlborough, MA – Boston Biomedical Associates (BBA), a strategic clinical and regulatory consultancy and full-service contract research organization (CRO) serving the medical device and biopharmaceutical industries, today announced an appointments to the company’s senior regulatory team. Mary LeGraw has been appointed to…

White Paper


Early Feasibility Medical Device Clinical Studies

On October 1, 2013, the Food and Drug Administration (FDA) released a final guidance document, “Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.” This guidance was developed to facilitate the early clinical…

White Paper


Counting Down: eMDR Compliance Deadline is Fast Approaching

As most companies and individuals in the Medical Device Industry are aware, on February 13, 2014 the FDA published a final report requiring manufacturers and importers to submit all Medical Device Reports (MDRs) in electronic format. The compliance date of August 13,…

Fact Sheet


Updated FDA Requirements for AED Systems

Effective on February 3, 2015 the Food and Drug Administration issued a final order requiring premarket approval applications (PMA) to be filed for automated external defibrillator (AED) systems and accessories (such as pad electrodes, batteries, and adapters). This order was prompted by…

News & Events


New BBA Corporate Headquarters

Now situated in the heart of greater Boston’s MetroWest biosciences corridor, Boston Biomedical Associates is perfectly poised to grow with you as your strategic partner in bringing new medical device technologies and pharmaceutical products to market. Although our address has changed, our…

White Paper


Deciphering the Unique Device Identifier (UDI) Code

Three letters have caused quite a stir in the medical device industry. U. D. I. What does it mean? How does a company comply with the new rule? Fortunately, Unique Device Identifiers are not as daunting as they first appear, and they…

News & Events


The Capital Network “Life Science Fast Track”

November 18, 2014 Boston, MA Mack Rubley, Vice President Consulting Services at BBA spoke at the Life Science Venture Fast Track event on November 18, 2014 in Boston on the topic of Regulatory Strategy. The meeting was attended by entrepreneurs and investors…

Press Release


6th Annual UDI Conference October 2014

The 6th Annual UDI Conference held in Baltimore, MD on October 28th and 29th was highlighted with the following takeaway points that may impact your business: The prevailing belief that UDI system will ultimately benefit your company as well as your customers…

White Paper


A Review of Regulatory Changes around the Globe

Since 2013, there has been a flood of changes to Medical Device regulations around the world. Many countries are attempting to modernize their regulatory controls over Medical Devices to allow for increased patient safety and greater access to medical devices. Staying abreast…

Press Release


Boston Biomedical Associates Announces Senior Management Appointments

Marlborough, MA – Boston Biomedical Associates (BBA), a product development consultancy and full-service contract research organization (CRO) serving the medical device and biopharmaceutical industries, today announced three key appointments to the company’s senior management team. Ken Dhimitri has been appointed to the…

Press Release


BBA’s Dr. Bonnie H. Weiner Receives Medical Society Distinction

Northborough, MA – Boston Biomedical Associates (BBA), a medical device development and biopharmaceutical services organization, is proud to recognize Bonnie H. Weiner, MD, MSEC, MBA, MSCAI, FACC for her outstanding achievement in the field of Interventional Cardiology. Dr. Weiner was selected to…

White Paper


New Medical Device Regulations in the European Union

Ever since the new EU medical device and IVD regulations were proposed in September 2012, the medical device industry has been attempting to gain a firm grasp on what they need to do to be compliant and prepared. There has been talk…

White Paper


Pathways for IDE Approval: Which Best Fits Your Needs?

There are several options for sponsors who are seeking IDE approval or FDA feedback regarding an IDE. Each option offers different benefits, depending on what type of trial the sponsor is seeking to initiate and how much time the sponsor is looking…

News & Events


CEOCFO Magazine

Boston Biomedical Associates President and Founder, Dr. Lauren S. Baker, is interviewed by Lynn Fosse of CEOCFO Magazine – 2/17/14 In her interview, Dr. Baker shares what she believes makes Boston Biomedical unique in the CRO universe (we bring a more comprehensive…

White Paper


De-Mystifiying the De Novo Process

The De Novo process was first introduced in 1997 with the implementation of the FDA’s Modernization Act (FDAMA). [1] It was meant as a means to reclassify novel devices of low to moderate risk profiles that were automatically deemed Class III because…

Press Release


BBA To Be Featured at Society for Clinical Trials Meeting

Northborough, MA – Four senior members of Boston Biomedical Associates (BBA) Biostatistical Department will present abstracts at the 34th Annual Meeting of the Society for Clinical Trials in Boston in May. The Society for Clinical Trials is an international community of professionals…

BBA News and Blog

Want to be updated on the latest news and insights from our team?

You have Successfully Subscribed!

Let's Keep in Touch!

Stay updated with our latest news and insights delivered to your inbox.

You have Successfully Subscribed!

MENU