In 2015 and 2016, there were over 150 major medical device company acquisitions and mergers, and that trend has only accelerated in 2017. These events often bring important questions regarding quality that can have far-reaching consequences if not addressed thoroughly by both department and company leadership.
We've compiled insights from experts with firsthand experience helping device manufacturers make informed decisions when integrating quality systems and performing the due diligence necessary to ensure compliance in both the short and long term.Continue Reading
On October 24, FDA finalized two guidances offering insight into when a new 510(k) is required following changes made to medical devices or the software powering them.
The drafts of these two guidances were released in the fall of 2016, five years after FDA's initial attempt at replacing its 1997 guidance outlining 510(k) changes. Deciding When to Submit a 510(k) for a Change to an Existing Device (“2016 Device Change Guidance”) revised FDA's 1997 guidance of the same name. The other, Deciding When to Submit a 510(k) for a Software Change to an Existing Device (“2016 Software Device Change Guidance”), presents guidelines for particular software changes.
Regulators have stated that the final versions of the guidances have been updated for clarity and to ensure they are interpreted consistently by agency staff and device manufacturers.Continue Reading
As reported in a recent Regulatory Focus article for the Regulatory Affairs Professionals Society (RAPS), officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP), confirming a fast-approaching deadline.Continue Reading
Despite the rapid rise in combination products over the past few years (an industry some predict to reach $115 billion by 2019), complex regulatory hurdles remain a persistent problem for firms bringing these new products to market.
Approving a combination product is anything but simple. Manufacturers must meet the requirements of a product's biologic and device requirements, naturally opening the door to a myriad of compliance risks.Continue Reading
Join Larry Stevens, RAC for a free webinar presentation covering the major topics of quality system harmonization.
Larry has held almost every field position within FDA during his 21-year career with the Agency. He has over 18 years of experience in the medical device industry, rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.
In this webinar, Larry unpacks the big decisions that lie ahead of company leaders before and during a merger, acquisition, or technology transfer and presents a model for companies to follow.Continue Reading