News & Blog

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  As an early-stage medical device company, balancing quality assurance, regulatory compliance, and [...]

Regulatory Complete Rewrite of ISO 10993-1 Creates Industry Buzz The proposed draft for the next revision of [...]

From reimbursement challenges, regulatory clarity for low-risk devices, to the rise of AI in home health, here [...]

FDA is releasing a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA [...]

According to the most recent "U.S. Product Safety And Recall Index" report by Sedgwick, manufacturing defects [...]

In medical device engineering, the pursuit of elegance in design goes far beyond surface aesthetics, embodying [...]

Read about AAMI and BSI partner is to publish guidance on artificial intelligence and reimbursement lags for [...]

Wearable motion sensors are everywhere, including in smart watches and fitness trackers. Because of this, it [...]

Read about the FDA-issued Marketing Submission Recommendations and the new rules the EPA has proposed for [...]

In the world of data management, maintaining clean and accurate databases is key to the success of any organization.

Last Month, I traveled to the NIH headquarters in Bethesda, MD for the semi-annual meeting of the External [...]

There are some tools that punch above their weight, and with some beautiful math, can produce powerful [...]

In our last article, we discussed how Simbex’s approach to diagnosing and resolving performance issues [...]

The word diagnosis is made of up of two Greek roots meaning “to know throughout” or to “understand [...]

Regulatory Ready or Not, Here Comes Medical Device Cybersecurity Legislation Late last year, President Joe [...]

Regulatory bodies around the world mandate that medical device companies adopt a “risk-based approach” to [...]

The hazard analysis is pivotal to your medical device’s risk management file. ISO 14971 defines a hazard as a [...]

ISO 14971 is the international standard that outlines the risk management process for medical device [...]

Every month for the past five years, Simbex has published our Regulatory and Reimbursement update, a briefing [...]

Regulatory, IMDRF guidance aims to harmonize, streamline review reports. The International Medical Device [...]

The U.S. health innovation landscape is among the largest globally, making it an attractive target for [...]

Regulatory, FDA final rule reduces radiological devices reporting requirements. FDA announced a final rule on [...]

Hello Everyone, I hope your 2023 is off to a great start! We have some exciting, albeit bittersweet, news to [...]

Regulatory, MDR: MDCG offers workaround for legacy devices with expiring certificates. MDCG said for [...]

The end of every year provides a time of both reflection and anticipation. Throughout the past five years, the [...]

Regulatory, FDA clarifies definition of devices vs. counterfeit devices. FDA has published draft guidance [...]

Regulatory FDA launches TAP Pilot to speed access to safe and innovative medical devices The FDA has launched [...]

Regulatory FDA finalizes guidance on how clinical decision support software is regulated FDA has published [...]

Regulatory FDA creates new category of OTC hearing aids, issues PSAP guidance FDA finalized a much-anticipated [...]

Every month, I try to offer some perspective on Simbex and how we strive to improve the world in which we [...]

Regulatory FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health FDA [...]

A reflection on the 12 months following an Agile-Transformation. Simbex had been moving in that direction for [...]

Regulatory FDA adds transition period to electromagnetic compatibility final guidance (RAPS 6/6/22) FDA [...]

Regulatory Medtech groups want more time to implement FDA’s QMSR rule While the medtech industry is [...]

The Upper Valley is home to a growing number of MedTech companies that are changing how we detect, monitor and [...]

Last year, we shared results from our Commercialization team's joint efforts with the Dartmouth Innovations [...]

Regulatory US FDA’s latest medical device cybersecurity guidance: Key differences from previous versions [...]

Regulatory MDUFA V: US FDA sets performance goals for De Novo medical device reviews MDUFA V will set [...]

Regulatory US FDA formally proposes aligning Quality System Regulations with ISO 13485 The US Food and Drug [...]

Regulatory FDA misses MDUFA V deadline after months of contentious talks FDA has failed to send the final [...]

Regulatory  FDA expands eSTAR filing to de novo devices, IVDs US medical device and in vitro diagnostic [...]

Regulatory FDA issues draft guidance for device software in premarket submissions The US Food and Drug [...]

Regulatory FDA nixes GUDID submission requirements for class I consumer healthcare devices Manufacturers of [...]

Regulatory FDA issues draft guidance on electronic 510(k) submissions The US Food and Drug Administration [...]

SAN DIEGO, CALIFORNIA – September 29, 2021 – Salona Global Medical Device Corporation (TSXV:SGMD) announced [...]

Regulatory FDA seeks more power for medical device cybersecurity mandates FDA is seeking “additional [...]

Regulatory US FDA rolls out final guidance on Unique Device Identifier (UDI) labeling requirements The FDA has [...]

Regulatory FDA issues final rule removing certain software from medical device regulations  The US FDA has [...]

Regulatory Device, digital health firms oppose HHS’ proposed 510(k) exemptions  Medical device and digital [...]

At Simbex, our holistic approach to product design centers on identifying risk at every stage of the [...]

Regulatory UK passes post-Brexit medical device regulatory bill into law The cornerstone of the UK’s [...]

Regulatory Safer technologies program finalized by FDA A newly finalized guidance from the FDA smooths the [...]

With the growth of medical device usage, the challenge for medical device developers and manufacturers for [...]

A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering [...]

A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering [...]

Researchers and engineers with great ideas sometimes need help getting their innovations from the concept [...]

A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering [...]

A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering [...]

FDA issued an immediately effective frequently asked questions guidance explaining its approach to inspections [...]

A Technology Review often begins with early assessment of the technology solution, which entails confirming [...]

Read the latest regulatory and healthcare reimbursement news, including the FDA exempts additional Class II [...]

Read the June, 2020 regulatory and healthcare reimbursement recap from Simbex, including the FDA expands [...]

A product requirements document is a collection of the many requirements that will define the expected [...]

As innovators ourselves, we recognize the opportunity to draw on the lessons-learned from this crisis, which [...]

The implementation of the Eudamed has been delayed by two years and the implementation of the Medical Devices [...]

Regulatory News MDR delay official as industry calls to push back IVDR The European Council voted 27-0 to [...]

Regulatory News FDA allows expanded use of devices to monitor patients’ vital signs remotely FDA does not [...]

On Thursday, March 26, a stay-at-home order was issued for New Hampshire residents, including the closure of [...]

Regulatory News New guidance published for Medical Device and IVD Cybersecurity under MDR and IVDR in Europe [...]

Regulatory News European Parliament Adopts Second Round of MDR, IVDR Corrigenda This change means that devices [...]

Regulatory News Fall Regulatory Agenda: FDA Delays Release of Several Proposed Rulemakings in April 2020, FDA [...]

A client recently told me, “Your team approaches product development problems differently than others – and it [...]

Regulatory News Device Firms Discuss Ethylene Oxide Sterilization Ahead of FDA Committee Meeting On 6 and 7 [...]

Simbex’s NIH-Funded Center for Translation of Rehabilitation Engineering Advances and Technology (TREAT) [...]

Regulatory News De Novo Requests: FDA Finalizes Three Guidances FDA finalized three guidance documents related [...]

Rick Greenwald has spent his life working towards making sports and medical devices safer. A couple weeks ago, [...]

Ian Wood has been working with Simbex as a Summer 2019 Marketing Co-op.  

This month, we launched our new website for ActiveStep®. ActiveStep® is an instrumented treadmill that uses [...]

Josh Posen has been working with Simbex as a Summer/Fall 2019 Product R&D Co-op. 

Regulatory News US FDA medical device user fees increase six percent for 2020 FDA medical device user fees for [...]

Regulatory News Sharpless Outlines FDA’s Key Priorities for Advancing Public Health Acting FDA Commissioner [...]

Regulatory News EC Cautions on MDR/IVDR Impact on Device Availability The European Commission acknowledged [...]

Chen Qiu has been working with Simbex as a Spring 2019 Software/Web Developer Co-op. 

Regulatory News CDRH Announces Implementation of Office of Product Evaluation and Quality OPEQ will integrate [...]

Last week, Simbex CEO Rick Greenwald presented at the ASTM Sixth International Symposium on Safety in Ice [...]

Regulatory News FDA Drafts Guidance on Inspections of Medical Device Establishments The three-page draft [...]

Click here to read more on NHBR.com.

Regulatory News CDRH Qualifies 3rd Medical Device Development Tool The OsiriX CDE aims to standardize how [...]

The Mayo Clinic is partnering with the American Joint Replacement Registry and the Thought Leadership & [...]

Regulatory News FDA-tasked Mitre Forges Ahead with Cyber Vulnerability Scoring System Tailored to Devices A [...]

Regulatory News Impact of the USMCA on the Medical Device Industry In the US-Mexico-Canada Agreement (USMCA), [...]

Simbex CTO, Jeff Chu, and I attended the Consumer Electronics Show in Las Vegas last week.  This year, CES had [...]

2018 Trends in Medical Device Reimbursement Telehealth: improvements in coverage and access No one can ignore [...]

2018 Trends in Medical Device Regulation The continued trend of consumer tech disruptors entering MedTech via [...]

Rick Greenwald among 16 recipients honored at 16th annual award reception on Nov. 1 Lebanon, N.H. – November [...]

General | Software | Rehab & AT | Injury Prevention | Pain Management | Real World Evidence [...]

General | Software | Rehab & AT | Injury Prevention | Pain Management | Real World Evidence [...]

General | Software | Rehab & AT | Injury Prevention | Pain Management | Real World Evidence [...]

The Center for Translation of Rehabilitation Engineering Advances and Technology (TREAT) was presented with [...]

General | Software | Rehab & AT | Injury Prevention | Pain Management | Real World Evidence [...]

General | Software | Rehab & AT | Injury Prevention | Pain Management | Real World Evidence [...]

When do you know that you have completed requirements gathering and that your documentation is sufficient to [...]

Simbex Chief Business Development Officer, Greg Lange, reports on what he saw at this year’s BIOMEDevice [...]

Washington, DC – The American Institute for Medical and Biological Engineering (AIMBE) has announced the [...]

Kavita Baradur has been working with Simbex as a Spring 2018 Engineering Co-op. Learn more about her in our [...]

With so much changing in healthcare, we keep our finger on the pulse of medical device regulation and [...]

The NIH-funded Center for Translation of Rehabilitation Engineering Advances and Technology (TREAT) is seeking [...]

Greg Lange, Simbex Chief Business Development Officer,  was elected as Chair of the Board of Trustees for the [...]

Simbex welcomes Jomkit Jujaroen from Rochester Institute of Technology as a Spring 2018 Engineering Co-op. [...]

“Ground-breaking research could change the lives of millions.” You have read the headlines, but what happens [...]

For a fourth year, NEPDC has announced funding and in-kind service support for solutions targeting a specific [...]

Changing the Game: Simbex evolves from measuring head impacts to developing a variety of medical devices. Read [...]

USA Hockey hosted its 2017 Annual Congress in Colorado Springs, Colorado. The four-day event provided USA [...]

Greg Lange joins Simbex as Chief Business Development Officer. Greg brings to Simbex 25+ years of healthcare [...]

Jonathan Beckwith is promoted to Vice President of Research and Development. Jonathan was previously Director [...]

CEO/President Rick Greenwald is elected to the National Academy of Inventors as a Fellow, the highest [...]

An associate professor of engineering at Dartmouth College, Kofi Odame was looking for a problem he could [...]

Four winners announced in 2016 Target Challenge grant competition held by New England Pediatric Device [...]

The U.S. Small Business Administration (SBA), through its Office of Investment and Innovation (OII), Office of [...]

Riddell releases an updated version of InSite Player Management (ISPM 3.0) that revolutionizes head impact [...]

Say that you have an idea for a product that would not only help someone regain independence after an injury, [...]

Retired Dartmouth engineering professor Robert Dean holds 28 U.S. patents, with five more pending. Dean is the [...]

InSite Impact Response System® is a 2014 NH High Tech Council Product of the Year Finalist.

InSite Impact Response System® is a 2014 Edison Award Gold Medal Winner

Riddell’s new InSite system uses technologically advanced helmet inserts to alert sideline staff when football [...]

The New England Pediatric Device Consortium (NEPDC), a non-profit research and education foundation aimed at [...]

“This is not a diagnostic tool.” That’s what Riddell, the country’s largest [...]

Simbex LLC has been selected for the 2013 New Hampshire Excellence Award amongst all its peers and competitors [...]

The New England Pediatric Device Consortium (NEPDC), a non-profit research and education foundation aimed at [...]

Simbex is recognized for it‘s strong year‐over‐year growth on the 2012 Inc 5000 List.

Over the last decade or so, researchers have worked tirelessly to zero in on just what happens to a player’s [...]

In an effort to alert coaches and trainers to a head hit warranting investigation, players at several colleges [...]

Simbex has developed a tiny accelerometer that fits inside helmet padding, measures sudden movements of the [...]

There is a growing awareness that football players, from the high-school to the professional level, can suffer [...]