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8 Common Healthcare Compliance & Regulatory Challenges & Their Solutions

8 Common Healthcare Compliance & Regulatory Challenges & Their Solutions

Every healthcare organization needs to comply with several regulatory requirements and regulations. Considering the ever-evolving regulatory frameworks, we understand that…

Streamlining Healthcare Regulatory Compliance | Everything You Must Know

Streamlining Healthcare Regulatory Compliance | Everything You Must Know

In the realm of healthcare, regulatory compliance stands as a cornerstone demanding precision and vigilance.  Adhering to regulations, laws, and…

Most Trusted Medical Device Regulatory Consultants in The US (2024 Update)

Most Trusted Medical Device Regulatory Consultants in The US (2024 Update)

Every medical device manufacturer or company would agree with us when we say navigating through the regulatory playfield is one…

Everything to know about JCI Accreditation | Overview, Benefits, How to get one?

Everything to know about JCI Accreditation | Overview, Benefits, How to get one?

The Joint Commission International (JCI) is a non-profit international accreditation organization based in the United States. It’s dedicated to certifying healthcare entities…

Do’s and Don’ts in a Quality Audit

Do’s and Don’ts in a Quality Audit

Quality audits play a fundamental role in the establishment of a company’s Quality Management System (QMS). An audit provides the…

Most Frequently Asked Questions About EU CE Mark!

Most Frequently Asked Questions About EU CE Mark!

A EU CE Marking is a much sought-after symbol, as it allows companies to gain access to the large European…

Medical Device Import/Expert In USA (Regulations for Medical Device Importers & Exporters)

Medical Device Import/Expert In USA (Regulations for Medical Device Importers & Exporters)

Medical devices are one of the world’s most traded commodities. The United States stands top in both the export and…

10 tips to make your next Grant Application a success!

10 tips to make your next Grant Application a success!

A grant proposal is a set of documents that are submitted to a company with the specific goal of receiving…

510(k) Clearance | Recommendation Ensuring Minimal Delay!

510(k) Clearance | Recommendation Ensuring Minimal Delay!

In this article, we will be taking you through some effective recommendations ensuring there is no FDA 510k clearance delay.…

eCopy Medical Device Submission (How to create a successful eCopy?)

eCopy Medical Device Submission (How to create a successful eCopy?)

Table of Content ⦿ What does the term ‘eCopy’ mean?⦿ When an eCopy is needed?⦿ What are the steps for…

ISO 9001 | The Complete Guide To Quality Objectives!

ISO 9001 | The Complete Guide To Quality Objectives!

Quality objectives are important for any organization that seeks to improve quality management system (QMS) & maintain its ISO 9001…

Regulatory Outsourcing | The Two Staff Augmentation Models For Pharma Companies

Regulatory Outsourcing | The Two Staff Augmentation Models For Pharma Companies

Staff augmentation in regulatory affairs is a well-established and effective staffing strategy that strategically places skilled professionals within a pharmaceutical…

Medical Device Design & Development Guide!

Medical Device Design & Development Guide!

Imagine a world without medical devices: The lifesaving products that have revolutionized healthcare as we know it. From simple syringes…

International Standards for design to market for Wearable medical devices!

International Standards for design to market for Wearable medical devices!

Wearable medical devices have emerged as a ground-breaking technology, revolutionizing healthcare and empowering individuals to actively manage their health. These…

MDSAP Audit | Complete Guide!

MDSAP Audit | Complete Guide!

In the rapidly evolving landscape of medical device regulations, ensuring compliance with various international standards has become a significant challenge…

Importance of regulatory strategy

Importance of regulatory strategy

In the rapidly advancing realm of the medical device industry, where groundbreaking innovations continuously emerge, the role of regulatory strategy…

HIPAA Law Violations & Their Serious Consequences

HIPAA Law Violations & Their Serious Consequences

HIPAA (Health Insurance Portability and Accountability Act) is a federal statute that institutes rigorous guidelines overseeing the utilization, revelation, and…

Navigating the Regulatory Landscape: Challenges and Opportunities for Medical Device and IVD Startups

Navigating the Regulatory Landscape: Challenges and Opportunities for Medical Device and IVD Startups

For aspiring entrepreneurs venturing into the dynamic world of medical devices and in vitro diagnostics (IVDs), the journey towards bringing…

Pros and cons of hiring a medical device consultant

Pros and cons of hiring a medical device consultant

Navigating the intricate framework of medical device regulations requires a delicate balance between expertise, compliance, and innovation. For mid-sized medical…

ANDA or 505(b)(2)?: Choosing the Right Abbreviated Approval Pathway for Your Drug

ANDA or 505(b)(2)?: Choosing the Right Abbreviated Approval Pathway for Your Drug

Bringing a new drug to the market is a complex journey, rife with scientific, regulatory, and financial challenges. One pivotal…

13 Common Mistakes to Avoid in the 510(k) Submission

13 Common Mistakes to Avoid in the 510(k) Submission

If you are looking to market your cutting-edge medical device, which is low to moderate risk, in the United States…

A Complete Guide to Hiring a Medical device consultant!

A Complete Guide to Hiring a Medical device consultant!

Bringing a medical device to market is a complex and multifaceted endeavor that demands adherence to stringent regulatory requirements and…

510K Submission | How To Pass Through FDA’s “Refuse to Accept” Policy!

510K Submission | How To Pass Through FDA’s “Refuse to Accept” Policy!

If you’re a medical device manufacturer planning to introduce a new product to the U.S. market, obtaining clearance from the…

Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…

Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…

When it comes to introducing new medical devices into the US market, obtaining approval from the U.S. Food and Drug…

Difference between intended use and indications for use!

Difference between intended use and indications for use!

As a medical device manufacturer, you know that navigating the complex world of medical device regulations is no walk in…

Determining Whether Your Product is a Medical Device! (FDA Medical Device Classification)

Determining Whether Your Product is a Medical Device! (FDA Medical Device Classification)

Picture yourself working in the medical industry, but your focus is not specifically on medical devices. Your focus is on…

Top 5 Common Mistakes to Avoid in the 510(k) Submission

Top 5 Common Mistakes to Avoid in the 510(k) Submission

Table of Content ● 510(k) submission timeline● Incomplete or inaccurate device description● Lack of substantial equivalence● Inadequate testing or failure…

HIPAA Law Violations Types, Examples & How to Avoid Them

HIPAA Law Violations Types, Examples & How to Avoid Them

The HIPAA law is of significant importance in the healthcare industry. It was enacted to address the privacy and security…

Staying Ahead of the Game: A Comprehensive Guide in Navigating the EU MDR

Staying Ahead of the Game: A Comprehensive Guide in Navigating the EU MDR

As the medical device industry continues to evolve, companies must stay ahead of the game and adapt to the latest…

MDR Extension: Navigating the Latest Changes in European Medical Device Regulations

MDR Extension: Navigating the Latest Changes in European Medical Device Regulations

Introduction to EU MDR When it comes to placing medical devices on the market in the European Union, the Medical…

Know Your Food: Understanding the Facts About Food Additives

Know Your Food: Understanding the Facts About Food Additives

While food manufacturers must add additives to food products as required, however, it is also important to know the regulations…

How are Dietary Supplements regulated in the US?

How are Dietary Supplements regulated in the US?

What are Dietary Supplements:  Dietary supplements are additions to the standard diet which are quite distinct from the ingredients found…

Grant Process – All you need to know!

Grant Process – All you need to know!

A grant is often given to an organization by a foundation, company, or governmental entity and is defined as “a…

Canadian Regulations for Medical Device Manufacturers and Importers

Canadian Regulations for Medical Device Manufacturers and Importers

Let’s assume a medical device company wants to get into the Canadian Market to meet the requirements of many of…

What is so special about Harmonised Standards for medical devices and IVDs?

What is so special about Harmonised Standards for medical devices and IVDs?

The word “harmonised standard” means a “European standard adopted on the basis of a request made by the Commission for…

Change is inevitable – The dynamic world of Medical Device Standards and compliance

Change is inevitable – The dynamic world of Medical Device Standards and compliance

In the medical device industry, standards play a vital role in product conformity while also helping Manufacturers synchronize with requirements…

BS EN ISO 13485:2016/A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes

BS EN ISO 13485:2016/A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes

The release of the 2021 Amendment of ISO 13485:2016 has created a lot of curiosity amongst medical device organizations and…

Refuse to Accept – An important milestone for your device during the FDA review process

Refuse to Accept – An important milestone for your device during the FDA review process

Why RTA (Refuse to Accept)? The FDA conducts an acceptance review of a 510(k) submission (Traditional 510(k), Abbreviated 510(k), or…

Common pitfalls during the CE marking of a Medical Device or IVD

Common pitfalls during the CE marking of a Medical Device or IVD

Common pitfalls during the CE marking of a Medical Device or IVD A CE (Conformitè Europenne) Mark is mandatory for…

Quality — The key to customer satisfaction

Quality — The key to customer satisfaction

Quality in a service or a product is not what you put into it; it’s what the end user gets…

How do IVDs differ from LDTs? Confused? Here’s the key

How do IVDs differ from LDTs? Confused? Here’s the key

Diagnostic laboratories in today’s world face a slew of issues; from managing complicated test panels to handling ever-increasing sample quantities.…

All you need to know about a Premarket Approval (PMA) Submission — Route to the US Market for Class III medical devices

All you need to know about a Premarket Approval (PMA) Submission — Route to the US Market for Class III medical devices

The Federal Food Drug and Cosmetic (FD&C) Act established three regulatory classes for medical devices – Class I, Class II,…

A to Z of a Clinical Evaluation Report

A to Z of a Clinical Evaluation Report

One of the most integral parts of getting regulatory approval in the European Union (EU) is a Clinical Evaluation Report…

EU Classifications and Rules for CE Marking

EU Classifications and Rules for CE Marking

For the manufacturers trying to figure out ways to place their medical devices in the EU market, classifying their devices…

The US FDA Medical Device User Fee for the Fiscal Year 2022

The US FDA Medical Device User Fee for the Fiscal Year 2022

What do the applicants of 510(k) or other regulatory applications or companies looking to register or import need to pay?…

ISO 15223-1:2021 Medical Device Symbols – An indispensable part of labeling

ISO 15223-1:2021 Medical Device Symbols – An indispensable part of labeling

As we all know that symbols play a very important part in medical device labeling, hence it is critical to…

BS EN ISO 13485:2016/A11:2021

BS EN ISO 13485:2016/A11:2021

Medical devices – Quality management systems – Requirements for regulatory purposes The release of the 2021 Amendment of ISO 13485:2016…

What does CE Marking imply and why is it required?

What does CE Marking imply and why is it required?

Manufacturers must obtain CE marking for the products they want to sell in the European Union (EU). When a product…

FDA’s New Requirements: What the MR based Medical Device Manufacturers need to know

FDA’s New Requirements: What the MR based Medical Device Manufacturers need to know

For a manufacturer of medical devices placed in a Magnetic Resonance (MR) environment, it is important to show compliance with…

ISO 20417:2021 | Information to be supplied by the manufacturer

ISO 20417:2021 | Information to be supplied by the manufacturer

What information is to be supplied by the manufacturer? As we are very much aware that the ISO 20417:2021 standard…