MyBlueLabel

New week, same compliance insecurities?

Lasse Dahl — Tue, 29 Aug 2023 06:47:15 +0000

In MedTech and Life Science, there are too many companies that:

1) Fear audits due to lack of real overview of their regulatory documentation and compliance processes and statuses.

and,

2) Spend way too many hours doing meaningless activities, like filing, version controlling, printing, scanning, etc.

The right platform is a powerful tool that allows your company to transform compliance into a business advantage – instead of being an obvious disadvantage. Download our MedTech Guide to get free advice, knowledge, and insights on how companies can work-optimize, and stay innovative by using a cloud-based platform

The visionary compliance company MyBlueLabel attracts experienced profiles to the board of directors, including former BioPorto CEO, Peter Mørch Eriksen, as chairman of the board

mariuscrisan — Tue, 04 Jul 2023 22:23:41 +0000

Monday 28-MAR-2022, Thomas Magnussen, Marie-Louise Little, and Peter Mørch Eriksen officially joined the board of the fast-growing compliance company, MyBlueLabel Compliance Services.

At an extraordinary general assembly on March 28th. 2022, MyBlueLabel Compliance Services established a board of directors and completed an investment round of DKK 5 million, and will change the company structure from ApS to A / S. This activity is carried out to accelerate the market introduction of their products and support MyBlueLabel’s growth plans to help 200 SMEs in Europe before the end of the year.

The MyBlueLabel software solution is built to help Life Science companies accelerate the process of developing a quality management system that enables them to easily navigate the regulatory rules to which the companies and their products are subject. This helps the companies understanding the minimum requirements for obtaining market access. We really want to support innovative companies that develop products that increase the quality of life for patients and users. To be able to attract strong and experienced profiles to our company and boards supports our mission to help as many startups, small and medium-sized businesses as possible … says Kenn Milton, CEO, MyBlueLabel, and continues: Regulatory compliance should be a central part of any business. We believe that only when you have control over compliance and the regulatory area can you truly innovate – and we want to make compliance a way of life (the easy way).

We know of the regulatory ‘headache’ most companies in this industry struggle with on daily basis. MyBlueLabel presents an intuitive way of accelerating the regulatory framework while ensuring visual communication and transparency which is a business advantage for all companies … says Peter Mørch Eriksen. The companies who understand this will win market shares – now and in the future.

From the left Thomas Magnussen, Kenn Milton, Marie-Louise Little and Peter Mørch Eriksen

MyBlueLabel Compliance Services can proudly announce a new important client – FMC Corporation is a Leading Agricultural Science Company

mariuscrisan — Tue, 04 Jul 2023 22:23:10 +0000

FMC Corporation has more than 6,000 employees and the turnover exceeds 4.5 Billion USD.The signed contract covers the entire

Compliance Services welcomes FMC Corporation as new client in agricultural science.

mariuscrisan — Tue, 04 Jul 2023 22:21:39 +0000

Anders is a partner in Sustainia and former Innovation Director/Executive Director of IBM and we are very proud to have attract

Jump on the Green wave of Compliance and digitalization

Victor Nemery — Tue, 04 Jul 2023 22:17:20 +0000

We are becoming more data-driven – which is both a threat and an opportunity – why compliance is increasingly important

The acceleration of digitalization has led to an enormous increase in the amount and flow of data. Every day people absorb countless data through emails, phone calls, and database records. This data is then processed to turn into even more emails, phone calls, and database records. This happens all the way through any modern business supply chain and all this data is collected and stored as ‘unstructured data. Although this flow of data leaves concerns for exposure of sensitive data through hacking, it is a vault of opportunities. For instance, structuring data is increasingly used to help managers make better decisions within business departments such as strategy, M&A, and HR. A 2019 Survey conducted by NewVantage Partners states that 92% of the respondents have increased the pace of investments in Big Data and AI and 31% mention that they have a data-driven organization. Digitalization and Big Data have resulted in countless benefits including spending resources more efficiently, scaling impact businesses, and assist humans in their work. Fantastic companies founded in the US, like IBM, have made it their advantage to create platforms that use data to make a successful business – the US does without a doubt have some of the most innovative companies in the world.

But what about compliance?

Digitalization and general technological improvements require us to look back into our laws and reflect on whether they harmonize with real-world situations – think about the ethical use of data to protect individuals and find new ways to bring value to societies. Here are some examples of how new technologies rightfully require a change in regulations:

– GDPR is a privacy and security law that obliges organizations operating in the EU to follow certain procedures when handling personal data. This means that virtually every multinational corporation must comply with GDPR. The law came into force on May 25, 2018, and may lead to large fines if not compliant.

– The EU MDR (Medical Device Regulation) will come into force on May 26, 2021, and require companies selling products in the EU to meet stricter requirements to ensure the safety of patients using their products. In addition, the regulation takes into account many new technologies within software application / Health technology.

If companies do not comply with the new regulations it may lead to products taken off the market” says Kenn Milton, CEO of MyBlueLabel Compliance Services.

Kenn Milton, Founder and CEO of MyBlueLabel

– The EU Taxonomy Framework is a classification system for sustainable economic activities. It is an attempt to prevent greenwashing, clarifying when an activity is considered environmentally sustainable. Currently, large financial and non-financial companies and financial market participants (such as asset managers) will have to disclose how their financial products meet the EU Taxonomy criteria.

What do these new globally applicable laws have in common?

They are made by the EU, which continues to set the standards within modern compliance. We believe that there is a clear opportunity for the EU’s regulatory competencies to work closely together with innovative US companies to maximize societal and individual value in the US as well as in the EU, especially with a focus on Public-Private-Partnerships (PPP). “The next level of partnering, abbreviated “FNAPPP” – Foundations-NGOs-Associations-Public-Private-Partnerships, will come soon” says Sandeep Sander, Chairman of the Advisory Board for MyBlueLabel Compliance Services.

Nature is immensely complex, just like the ever-increasing amount of data that is accumulated in an unstructured form, often useless in its raw version. However, harnessing its potential and using it to improve environmental key performance indicators is a very promising opportunity. It could fx be used to reduce GHG emissions down the supply chain or to actively predict natural disasters. This could be used to ensure ‘Green Compliance’ a term that is used to describe any ‘hard law’ such as environmental regulations, standards, and site permits used by authorities. While there is a tendency towards an increased focus on ‘hard law’ we also witness how proactive companies increasingly demand documentation from their suppliers, ensuring that they meet sustainability standards, based on a voluntary scheme also described as ‘soft law’. For instance, Novo Nordisk and Chr. Hansen is demanding their suppliers to document the “degree of Green Compliance” when delivering services. An exciting tendency that proves that it is just as important to comply with ‘soft laws’ as these are pivotal to future relationships with key clients. It is my prediction that ‘soft laws’ will turn into ‘hard laws’ as the regulatory ecosystem strengthens. Software that helps you calculate CO2 emissions from activities along the supply chain such as transportation, or data dashboards that track, analyze and display your key data are clearly an advantage when you want to keep your critical clients happy and document your green compliance improvements. Running a business based on data-driven, sustainable principles is not “nice to have” anymore. Whether it is dictated by soft law or hard law, it is quickly becoming a “need to have”. Combining Green Compliance and Digitalization is the fuel of future businesses: It will help you provide your investors with green performance indicators – and make visible improvements to your positive impact.

Why a Quality Management System?

Victor Nemery — Mon, 19 Jun 2023 10:38:06 +0000

In this post, we will discuss why you need a Quality Management System.

There are two main reasons for implementing a Quality Management System:
– It is a requirement to get MedTech and Life Science products to the market.

– To run an effective business ensuring compliance becomes a business advantage.

“Quality or compliance is or should be a business advantage!”

Quality is the minimum expectation of any patient or customer paying for a product or service. How can it be that when the word “Quality” is mentioned inside a manufacturer or organization, it makes people run for the hills. Shouldn’t good quality be the top priority of any manufacturer in any industry? We are working in an industry where quality is essential for devices to be safe and effective – so why is quality not first in mind, when introducing new innovative products to the market?

If you, or someone you love, were the patient, of the device you are manufacturing, what would be your own minimum expectations to be met by the manufacturer? Would you, as a minimum, expect that the device was tested to be safe and work as intended, and know you could get help if required?

We are so fortunate, that experienced organizations have already defined what is required to deliver quality products to the market. It is true that some companies have been interpreting these directives in a way which resulted in harming patients, which in turn requires for the requirements to be strengthened. As an example, this new regulation introduces the need for an increased number of companies, to implement a Quality Management System.

Setting up a system for quality should be the first priority and minimum expectation for any company that wants to go from a hobby project to a professional business. Your customers expect you to run a professional company, no matter if your customer is a layperson, healthcare professional, or a business.

Management System

If you want to run an effective business, you will need to introduce a set of procedures, that will help onboarding new personnel, harmonize processes, avoid rework, and ensure a uniform output. If there is a possibility to enhance these procedures to work even more efficiently, then it should be considered. It will make better use of available resources. This is simply good business practice.

You should author a procedure for any process in the supply chain that you are doing. When you need to author a document is it important to have a Document Management procedure. If you are doing any work in a GxP (regulatory) environment, you must be qualified for your role, according to a Training Management procedure. For Risk Management you need to have a Risk Management Procedure. This is to ensure, that all personnel are following the same processes. It just makes a lot of sense.

When you are in control of your business you can put “Quality” back into Management Systems, and you will be meeting the ISO requirements and Regulatory Requirements. Quality Management System is nothing but ensuring that you are running an effective business while ensuring general safety and performance requirements.

The most important part of the workday is lunchtime. I don’t see your task in Jira so that means you didn’t work in this sprint. Can we attempt some other colors maybe just do what you think? I agree with you, yet desires to be smoother can you are making it appear like this clipart I created nor are we able to have any other option, for making it look like Spotify, or I want you to take it to the next level. I don’t believe that you did some unit tests. Send me the password in plain text on email. Hurry up! Let’s do the Secret Santa Party in November. The client said that he just want a website to generate data, nothing more, now he told us what he means is a website like Facebook.

Business Assurance

For how long can your company key resource be away from their job before it impacts your business? 1 day, 7 days, 1 month? What if your key resource leaves your company, how do you ensure that all the knowledge remains in the company? Knowledge sharing and Document Management should be the minimum requirement to ensure that information is captured. When sharing information, you should have a controlled mechanism for storing and updating information. If you just learn to store documents, use version control, and share documents through a controlled storage area, then you are already covering 80% of the expectations in a Quality Management System.

I do not need one!

It is typical that smaller companies think it is too early to implement a quality management system, as “they are still in the innovation phase”. Another concern is that only larger corporations can afford to have a Quality Management System. However, now it is possible for the smaller companies to work better and faster. When the requirements are known in the beginning of the project, it will save yourself from a lot of grief and heartache. When you send the first email with a document review or you have been working in the same project for more than one month, you could already have benefited from having a Quality Management System. When you are discussing the device intended use, description, and initial design, you should already think about what the correct details to consider are.

Even if you are manufacturer of a Class I product, you will need to create a Technical File. The technical file must include requirements, testing, and you will still have obligations in a Post-Market scenario including collection of incidents, complaints, reporting of serious adverse events and making CAPAs. The EU declaration of conformity and the technical file must be available upon request for 10 years after the last device has been placed on the market. It can seem obvious that even though an electronic document management system, with version control and electronic signature is not required, it might be of help to introduce one.

Learn from people who have done this before.

If this is the first medical device you are producing, you might be in the prototype phase, until someone is kind enough to remind you that you need a Quality Management System to be able to continue into Clinical Investigation. If you are on this journey for the second or third time or more, you already know that a Quality Management System will also help you minimize rework and focus on what matters.

Why should you want one now?

You should know the end before you begin. If you know the requirement before you begin your journey, chances are that you are not doing any unnecessary extra work, which is no value add. Time is ruthless and is not going to slow down because you went down the wrong path. Stay focused and goal-oriented.

Quality By Design

You need to find a solution, which makes you run an effective business. If the quality management system activities take away all your creativity or time, you might need to think about getting a new system in place. If your quality management system, does not help you to focus on what matters, you need to find a new system. You need to find a system which is easy to onboard, easy to use, and when using it, quality is enabled by design.

Medical Device Regulation

The Medical Device Regulation, MDR will be enforced in May 2021. In this regulation, new classification rules are introduced. It is essential to establish the correct risk class of each individual device with classification rule(s) in accordance with MDR, Annex VIII – Classification Rules. A Quality Management System, which is appropriate to the risk class, is required, by medical devices risk classes above Class I. The minimum requirements expected for a Quality Management System is listed in Article 10(9) – Obligations of the manufacturers. Furthermore, the ISO 13485 – Medical devices — Quality Management Systems details the requirements on how to implement and maintain a Quality Management System for Medical Devices. Risk Management and Post-Market Surveillance activities and tracking of the two, are in focus. Therefore, it makes sense to look for a Quality Management solution where it is possible to register and track the risks and opportunities in each supply chain step against reported incidents, while ensuring the MDR, Annex I – General Safety and Performance Requirements are met.

Conclusion

The recommendation is, to get some help to start the journey right. Do regular reviews to ensure processes are effective and technical documentation is relevant. In the end, a Quality Management System is a business advantage.

Victor Nemery