Regulatory, Reimbursement, Standards and IPHow to go beyond the regulatory requirements checklist
Many manufacturers run into issues as they adjust their devices and testing plans to meet updated regulatory requirements. Using a risk-based approach to predict and mitigate risks can help prevent costly setbacks.
WuXi AppTec – 2020
Using a properly formatted “roadmap” can help a medical device development team realize that the regulations are structured to yield innovation rather than stunt it.
MIDI Medical Product Development – 2020
Working through the regulatory requirements for IVD devices in your target markets can mean a successful launch into an industry segment poised for great growth in the coming years.
Intertek – 2020
COVID-19 has caused many companies to hunker down, protect the status quo and embrace a conservative mindset. But some are taking this time to seek out intellectual property (IP) opportunities.
McAndrews, Held & Malloy – 2020
It’s important to avoid missteps while protecting your medtech company’s innovations. Top Greenberg Traurig attorneys explain how.
Greenberg Traurig – 2020
For many devices, the cost of compliance with MDR and IVDR will be high and will require significant expertise. Manufacturers should immediately begin developing a strategic business model that will prepare them for success under the new reforms.
Icon – 2019
ISO 13485 provides quality management system (QMS) guidelines for the production of safe and effective medical devices, but it’s easy to get tripped up.
Greenlight Guru – 2019
Medtech is rapidly changing. Here’s how Greenberg Traurig experts think the shift will affect liability and IP protection.
Greenberg Traurig – 2019
The deadline to comply with new medical device regulations in the European Union is coming up fast. Here are some ideas on getting ready for the changes.
Sparta Systems – 2018
By developing a strategic patent portfolio quickly and successfully, medtech companies can navigate a path to commercial success.
Greenberg Traurig – 2018
Post-market surveillance is an important process for medical device developers, with regulatory bodies expecting you to follow through and have effective procedures.
Greenlight Guru – 2018
Until recently, the main focuses of medical device companies were designing devices and earning regulatory clearance for their new technologies. How times have changed. While innovative design and FDA approval are important for market entry, reimbursement is now a top concern for medical device CEOs, their investors and other stakeholders.
RCRI – 2018
Contracts are underused by medical device companies. Here’s why they are worth a second look.
Medmarc Insurance Group – 2018
If your business manufactures, installs or services medical devices, you know it’s essential to transition to the new 13485: 2016 ISO standards as soon as possible.
EtQ – 2018
Medical device registration may seem straightforward but is actually prone to potentially costly mistakes.
Sparta Systems – 2017
Patent protection is becoming increasingly important for mobile health developers as more devices and applications join the connected world.
Greenberg Traurig – 2017
Here’s how medical device makers can capitalize on the strategic priorities and transparency initiatives at FDA’s CDRH.
RCRI – 2017
All companies begin with an idea. The details of protecting intellectual property, however, can be daunting, especially if your idea is in the field of medical technology.
As connectivity features become increasingly prevalent, developers are tasked with accounting for regulatory implications in increasingly long-term plans.
Ximedica – 2017
New regulations are coming to the European Union, and it’s up to developers to implement changes that will help them thrive in the new environment.
Icon – 2017
Embolic protection devices could reduce risks of interventional cardiac procedures such as TAVR, but their efficacy is hard to prove.
Novella Clinical – 2017
When outsourcing medical device laboratory testing, knowing what the regulatory and business requirements are up front is critical to the success of your testing program.
Cybersecurity is becoming an essential pillar of medical device design, and it’s important to find the right strategies to validate and verify your products are secure.
Intertek – 2017
Capturing data during a product’s manufacturing process can help ensure the quality and consistency of that product. Here’s how that process plays out with fastener torque.
Futek – 2017
In an increasingly competitive medical device industry, it’s still important that validation and testing is done right. Here are four things to keep in mind.
Jordi Labs – 2017