medical equipment

Understanding ISO 13485

ISO 13485 is an international standard of quality for medical devices. The International Organization for Standardization awards this certification, and it is aimed at ensuring devices used in the medical industry are of the required quality. Once a manufacturer meets all the requirements of the quality management system (QMS) of medical devices, they can then be issued with this ISO certification.

If a manufacturer has been issued with the ISO13485 certification, it has adhered to the EU Medical Device Directive, Medical Devices Regulations. They have also adhered to any other rules aimed at making sure devices for the medical industry are safe and of good quality.

What is the ISO 13485 certification?

cerification for high qualityISO 13485 certification is divided into two types. The first type is the certification issued when a company specializing in medical devices production develops and implements a QMS that meets the ISO 13485 standards. The second type refers to the certificate issued to individuals or companies that allows them to audit other companies to confirm whether they have met the requirements of ISO 13485.

What are the requirements before being issued with ISO 13485?

ISO 13485 spells out all the requirements a company that has implemented QMS must conform to produce medical devices and any other related device of the ISO standard. These devices must meet not only the regulatory requirements but also the customer needs. Irrespective of the size, if a company specializes in manufacturing medical devices, it must meet all the ISO 13485 requirements before getting this certification.

ISO 13485 is made up of 8 parts; the first three are the introductory parts, while the remaining five spells out the requirements a QMS must meet. Section 4 is about QMS requirements, section 5 about management responsibility, section six is about managing resources, section 7 focuses on product requirements, and section 8 speaks of measurement, analysis, and improvement. You cannot receive an ISO 13485 certification without conforming to all these.

Is ISO 13485 mandatory for all organizations?

A company must not be ISO certified, but customers tend to trust devices or products from a company that is ISO certified. ISO certification is an indicator that a company is adhering to top standards in manufacturing their products. You can still be allowed to produce medical devices without ISO 13485 as long as your company QMS conforms with all legal requirements for making medical devices.

Getting an EU MDR compliance does not require you to be ISO 13485 certified. You can get the certification if you have a regulatory compliant QMS. However, the QMS standards that must be met are the same as those of ISO 13485, making manufacturers use ISO 13485 to create and implement their QMS.…

marketing team

Tips for Hiring a Marketing Agency For Your Business

Hiring a marketing agency is an effective way of promoting your products and services to the outside world and attracting more customers. The team hired will be responsible for promoting and bolstering your brand online. This means that you should make sound decisions when hiring a marketing firm. Marketing is one of the necessary tools for business growth.

marketing strategies

This post is going to enlighten you on how to choose the right marketing firm for your business needs. Working with the best marketing agency can help you in competing with other firms that have experienced marketing teams. The marketing recruitment agency has launched its B2B recruitment  survey whose working styles and personalities match the dynamics of various companies. They can help you in boosting the visibility of your brand. Outlined here below are the proven tips for hiring the right marketing agency:

Consider The Size of The Marketing Firm

Check whether the potential marketing firm is small or well-known. Different sizes have the own qualities. Most of the large firms are known for having lots of resources, and they can comfortably handle large projects. These firms have a team of well-trained developers. They can identify what works well for your business since they have handled many similar projects in the past.

On the other hand, small agencies have a team that is much more concentrated, and they have all the time to study the changing market trends. This means that they can quickly react to changes that may arise and make the necessary adaptations. They can easily keep up with the changing marketing trends by employing cookie cutting strategies. In other words, small marketing teams are more flexible compared to the large ones.

Transparency

transparency-honesty

Business owners should have a clear view of their project’s details. You should work with a marketing firm that is transparent enough. They should let you know what is expected at the end of every meeting. This will make you more confident when making key marketing decisions. Most of the credible firms are known for bringing their clients aboard and showing them how things work. A reliable agency should avoid beating the bush if the client asks questions.

Committing Before Submitting

You should avoid committing your time and resources on something that you are not sure whether it works. You should hire a marketing agency that will be around as long as your business is running. Ideally, you should share the same principles and vision. Are you confident in the abilities of the selected marketing agency? You should discuss your long-term goals with the chosen agency.…

offer

Important Things to Ask After Getting a Job Offer

The process of job finding is a challenging and stressful undertaking that everyone has to go through at some point. When it comes to finding a job, there is a long list of what you should do correctly. However, when you get a job offer, the process doesn’t stop there. There are several considerations that you need to know before you sign on to work in that company and accept your job offer.

When finding a job, you don’t want to work in a random type of position that you just so happen to get. You want to make that job your career. That is why before you accept a job offer, you need to speak with the company and ask for further information.

It is essential that you contact the HR of the company to ask further questions regarding the job you are offered. In this article, we are going to tell you some vital information that you need to ask your potential employers before you accept the job offer that is given to you. Here are some important things to ask after getting a job offer:

Benefits, Salary, and Other Perks

benefitsThe most crucial things that you have to inquire before you accept the job offer is to ask about the benefits, the salary, incentive compensation, relocation, amenities, and other perks. When it comes to benefits and pay, you need to know what the benefits package includes and you also need to know whether or not the salary is negotiable.

You should also ask about the perks that you will get if you are hired. Find out what amenities and opportunities are there for you to take advantage of while you are working there.

Community and Convenience

The sense of community and convenience is also a huge consideration that you need to keep in mind. Ask around about what other employees think about the company itself. Get a feel of whether or not you think you will fit in with the company’s culture.

Other than that, you should also find out about the ease of getting information and other forms of conveniences. Discover whether they have a system such as JCP Associate Sign in site or not to make it easier for you to access information.

Ask for Everything in Writing

written agreementLast but certainly not least, ask to have the job offer as well as everything you have agreed on in writing. This extra step ensures that the employer will not pull back on the offer if you accept it. An agreement that is written is a lot more binding, and it is also a great way to solidify the deal.…

work

The Right Way to Do Interviews

For someone who just graduated from university, going to an interview can be a terrifying experience if it is your first time. And even if you have been in an interview, going again after a while will give you the nerves as well. Read this article to make sure that you will have a successful one.

Feel good about what you wear

Believe or not, looking good can make you feel ten times better in the interview. Find a look that is appropriate for the event, and you will step into the room with confidence. This tip will help you not to get as nervous knowing that you are looking your best. Aside from that, the interviewer will also appreciate the effort of you dressing up and being professional, which means that you are taking the occasion seriously. You don’t want to come in looking like a mess because this will do the opposite of getting you the job.

Do your research

researchThe one thing that will get you rejected is if you don’t put any effort into preparing for the internet. Imagine if you are asked about the company’s vision, and you can’t answer that question which makes it obvious that you did not do a research beforehand. That will make it look like you don’t really want to pass because you don’t even bother to look up the company’s profile. It will impress the interviewer more if you come prepared with the idea of what the company is doing, how long have the company been running, why the company is there, what they want to achieve, and overall knowledge about the position that you are applying for.

Be confident and be yourself

interviewAs much as you want to get the job, it is more important to get the right job for you. And you can’t let the company make a fair judgment if you are faking the interview. You need to be yourself even if it does not go with the company’s values because the interviewer needs to know the real you. You can’t possibly be someone who you are not. Eventually, the truth will come out, or you will be miserable.

Ask questions as well

Assuming that you will get the job, you need to make sure that you are not making the wrong choice by working for that company. For this reason, you need to prepare several questions and have criteria for your ideal workplace, environment, salary, and other things.…

internship

How Internships Can Help You To Find a Job

If you are still in university, there are a lot of things that you need to do besides studying. And I am not talking about partying because we all know that we usually go to too many parties than we should have during our years being a university student. What you need to take and get your hands on is internship experience. To go for an internship is different with your part-time job during the summer. A part-time job is when you make money out of working at a shop, restaurant, retail, and many others where you are not working in an office. But with an internship, you will do more task from behind the desk and take some responsibilities as an employee of a company.

Bigger chance to get a job

Your grades are just one of a way for the company to filter candidates from their application, but it will not get you the job. The human resource department is far more interested in what have you done and what experience do you have. This part of the interview will reveal who you are as a student and what was your priority back then, is it just school and perhaps nothing else? Do you make time to do something aside from classes?

Working experience

internYour internship experience will give you a snippet of what working will feel like, and there are so many benefits that you can take. Aside from it will make it easier for you to get a job, you will also get a chance to look at the industry or company that you are doing your internship at and think whether you like it there or not, figure out what you dislike for your future reference. So you can graduate with a vision to know which company and what kind of industry that you want or does not want to work in.

Learn new skills

teamIt’s true that getting A’s on your grades and papers is not enough, GPA is not the only thing that you have to pay attention to because there is so much more to learn. Get yourself out there in the real world to know what the textbook won’t teach you. Self-development is what you will get from doing an internship, and it is what you need if you want to be more than the other graduates.…