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Making medical devices: Everything you need to know

September 2, 2021 By Chris Newmarker

Regulatory, Reimbursement, Standards and IP

remote clinical trials

[Image from Unsplash]

How COVID-19 changed medical device clinical trials forever

The success of remote clinical trial oversight opens the door to hybrid approaches and creates new possibilities for the future of trials.

DeviceTalks/Avania – 2021

 

Keys to protecting your medtech AI from competitors

AI is a hot area in medtech. A panel of intellectual property experts had advice on protecting the IP.

DeviceTalks/Finnegan – 2021

 

3 questions medical device manufacturers should ask before ISO 10993-17 updates

The upcoming publication of ISO 10993-17 will support the latest ISO 10993 expectations already in place. Gain insights into what this standard will mean to the evaluation process and how to prepare in advance.

WuXi AppTec Medical Device Testing – 2021

 

Introducing ‘BYOP’ clinical trials

The company Curebase is promoting the concept of ‘bring-your-own-physician’ clinical trials.

Curebase – 2021

 

Taking the extra steps to ensure medical device quality assurance

Here’s how medical device manufacturers can go the extra mile to address regulatory challenges and user needs with comprehensive and purposeful quality assurance systems.

Eitan Medical – 2021

 

How 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

 

Here’s how you embrace regulatory controls to map medtech innovation

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

 

Navigating regulations for in vitro diagnostics

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

 

Look outside your company for IP opportunities during unprecedented times

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

 

5 keys to stronger medtech agreements

It’s important to avoid missteps while protecting your medtech company’s innovations. Top Greenberg Traurig attorneys explain how.

Greenberg Traurig – 2020

 

How to create a strategic business plan to ensure success under MDR/IVDR

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

 

Top 4 mistakes when implementing ISO 13485

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 product liability and IP: Here’s where it’s going

Medtech is rapidly changing. Here’s how Greenberg Traurig experts think the shift will affect liability and IP protection.

Greenberg Traurig – 2019

 

Ready or not: How medical device manufacturers can prepare for E.U. MDR

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

 

6 tips for quicker and stronger medtech patents

By developing a strategic patent portfolio quickly and successfully, medtech companies can navigate a path to commercial success.

Greenberg Traurig – 2018

 

5 tips for post-market medical device compliance

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

 

Your device design looks great: Now how do you get reimbursement?

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

 

Medtech contracts versus purchase orders: Why contracts might be the better option

Contracts are underused by medical device companies. Here’s why they are worth a second look.

Medmarc Insurance Group – 2018

 

Here’s what you need to know about the new ISO 13485:2016

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

 

5 mistakes that can turn your product registration into a money drain

Medical device registration may seem straightforward but is actually prone to potentially costly mistakes.

Sparta Systems  – 2017

 

How to protect your digital and mobile health innovations

Patent protection is becoming increasingly important for mobile health developers as more devices and applications join the connected world.

Greenberg Traurig – 2017

 

How to work with the new FDA

Here’s how medical device makers can capitalize on the strategic priorities and transparency initiatives at FDA’s CDRH.

RCRI – 2017

 

Intellectual property: How medtech startups can protect it

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.

Hamilton, Brook, Smith & Reynolds PC – 2017

 

Navigating the FDA for connected devices

As connectivity features become increasingly prevalent, developers are tasked with accounting for regulatory implications in increasingly long-term plans.

Ximedica – 2017

 

What you need to know about Europe’s new medical device rules

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

 

How to design a successful embolic protection devices clinical trial

Embolic protection devices could reduce risks of interventional cardiac procedures such as TAVR, but their efficacy is hard to prove.

Novella Clinical – 2017

 

How to work with a preclinical contract research organization

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.

Toxikon– 2017

 

Medical device cybersecurity: Here’s how you verify and validate it

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

 

Simplifying product testing and validation with fastener torque auditing

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

 

Validation and testing: What you need to know

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

Next>>

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  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • Subscribe to Print Magazine
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    • eBooks
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    • MedTech 100 Index
    • Podcasts
    • Print Subscription
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    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
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