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Know more about Wearable Medical Devices | Operon Strategist

The medical device industry changes constantly as new innovations and advancements are made in development, medical IT, and healthcare. Our medical device blog features expertise from the Sterling Medical Devices team and the latest information and regulation changes in the medical device industry that you should be aware of.

The healthcare and wellness industry is shifting toward regulated, personalized,…

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Added by Neha on October 18, 2022 at 2:41am — No Comments

What is the UKCA Mark for Medical Device?

UKCA stands for United Kingdom Conformity Assessed, and is applied to products placed on the market in the UK. This replaces the CE mark, which – pending changes to legislation - is recognised in the UK until the 30th June 2023. So from this date onwards, medical device manufacturers need to comply with the new UKCA marking regulations.

manufacturers now need to plan for how they will obtain a UK Conformity…

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Added by Neha on October 18, 2022 at 2:40am — No Comments

Consultation about FDA 510 k clearance and submission

What Does a FDA 510( k) Clearance mean?

Medical devices for human use within the United States must be submitted to the FDA to determine if the product is safe and effective. To do this, in utmost cases a company must compare their product to one formerly cleared by the FDA and give substantiation that their product is “ substantially equivalent ” to the preliminarily cleared( legally marketed) device. To be mainly original, the product…

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Added by Neha on September 30, 2022 at 1:47am — No Comments

ISO 13485 - QMS Medical Device Certification Consultant

The US Food and Drug Administration has published a largely anticipated proposed rule to harmonize its medical device quality management system( QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard. 

FDA’s proposed rule “ would harmonize quality management system conditions for FDA- regulated devices with conditions used by numerous other regulatory authorities around the world, ” the agency countries.…

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Added by Neha on September 30, 2022 at 1:44am — No Comments

ISO 14001: What is Emergency Preparedness and Response?

With any environmental management system (EMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.

This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your environmental impact when problems occur.



In the webinar we will look at:

  • What ISO 14001 means by an emergency…
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Added by Adam Fleming on March 10, 2020 at 8:13am — No Comments

ISO 45001: What is Emergency Preparedness and Response?

With any occupational health & safety management system (OHSMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.

This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your OH&S impact when problems occur.



In the webinar we will look at:

  • What ISO 45001 means by an emergency…
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Added by Adam Fleming on March 10, 2020 at 8:12am — No Comments

The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

Attend this webinar to learn how to understand control charts and their underlying statistics, how to choose variables to monitor, how to maintain the records and to plan adjustments.

There will be examples and walkthroughs of control chart implementation and use. A review of the relevant statistics will also be done.

Added by Adam Fleming on March 9, 2020 at 5:56am — No Comments

ISO 45001: What is Emergency Preparedness and Response?

With any occupational health & safety management system (OHSMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.

This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your OH&S impact when problems occur.



In the webinar we will look at:

  • What ISO 45001 means by an emergency…
Continue

Added by Adam Fleming on March 9, 2020 at 5:55am — No Comments

Supplier Auditing for Medical Device Companies

This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers.

Learn how to prevent quality and compliance problems by having a strong system for supplier audit and management! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for managing your suppliers.



You'll learn about the essential elements of…

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Added by Adam Fleming on March 9, 2020 at 5:54am — No Comments

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs.

Added by Adam Fleming on March 5, 2020 at 6:23am — No Comments

Production and Process Controls for Medical Device Companies

Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce safe and effective products.

Because Production and Process Controls are so critical they are one of the major subsystems emphasized in inspections by the FDA.

Failure to adequately implement Production and Process Controls (P&PC) can lead to disaster for your company or even worse for your customer. And…

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Added by Adam Fleming on March 5, 2020 at 6:22am — No Comments

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential…

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Added by Adam Fleming on March 5, 2020 at 6:21am — No Comments

Risk Management Courses, Preventing Absent Training

The US business environment as well as those of other countries have experienced over the years significant risk events with significant negative risk consequences. In recent times there have been a plethora of risk episodes in the corporate world.

Many of these episodes could have been avoided or modified if the entities…

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Added by Joseph Wilcox on March 5, 2020 at 4:19am — No Comments

Latest Courses On FDCPA, Regulatory Changes

How the Fair Debt Collection Practices Act Works.

The FDCPA does not protect debtors from those who are attempting to collect a personal debt. If you owe money to the local hardware store, for example, and the owner of the store calls you to collect that debt, he is not a debt collector under the terms of this act. FDCPA only applies to…

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Added by Joseph Wilcox on March 5, 2020 at 4:17am — No Comments

Ways To Manage Sensitive Dress Code, Dress Code Course

Communicating and enforcing dress code policies are essential. Learning to set and manage policies by working directly with internal managers, business partners and executives in handling issues such as inappropriate or provocative dress, unhygienic employees is important, as well as identify and mitigating any legal issues.(protected class…

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Added by Joseph Wilcox on March 5, 2020 at 4:15am — No Comments

How To Recover Your Failure As A Leader , Leadership Training

A leader does not necessarily manage, but a manager had better be a good leader.

Why is leadership so important?

Without leadership, nothing gets done. Leadership brings the vision and ideas, and sets the course or direction. Managers ensure execution.

People don't leave companies, they leave bosses. Leadership is the most…

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Added by Joseph Wilcox on March 5, 2020 at 4:13am — No Comments

How To Recover Your Failure As A Leader , Leadership Training

A leader does not necessarily manage, but a manager had better be a good leader.

Why is leadership so important?

Without leadership, nothing gets done. Leadership brings the vision and ideas, and sets the course or direction. Managers ensure execution.

People don't leave companies, they leave bosses. Leadership is the most…

Continue

Added by Joseph Wilcox on March 5, 2020 at 4:13am — No Comments

How To Recover Your Failure As A Leader , Leadership Training

A leader does not necessarily manage, but a manager had better be a good leader.

Why is leadership so important?

Without leadership, nothing gets done. Leadership brings the vision and ideas, and sets the course or direction. Managers ensure execution.

People don't leave companies, they leave bosses. Leadership is the most…

Continue

Added by Joseph Wilcox on March 5, 2020 at 4:12am — No Comments

Maintain Multi-Family Properties Course, Solve Property Issues

Students will have a good understanding of everything involved in setting up a maintenance plan for their property. They will be able to catch the "little" things before they become a costly emergency. In addition, they will be able to create an accurate, working budget which will maximize productivity and minimize…

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Added by Joseph Wilcox on March 5, 2020 at 4:00am — No Comments

New Payroll & Administration Rules,Overtime Rules Courses

This webinar covers the complete context of payroll rules and administration made simple. It starts with the basic classification of workers properly classified as Contractors or Workers.  Rules for Payment and administration of Contractors is outlined. Rules for workers   classified as "Exempt"  or "Non-exempt" based on FLSA .

Rules for payments to…

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Added by Joseph Wilcox on March 5, 2020 at 4:00am — No Comments

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