Your regulatory strategy

Your regulatory strategy

PLACING YOUR MEDICAL DEVICES ON THE GLOBAL MARKETS

General strategy

If your goal is to bring a medical device to global markets you need a strategy. As most countries tightly regulate their medical devices markets, you will have to gain a lot of knowledge and a full understanding of your target market’s regulatory framework before you go for it.

Regulatory strategy

In the case of medical devices market the regulatory strategy is one of the most important parts of strategic planning. Market regulations pose the first hurdle a manufacturer must overcome to put their medical devices on a market. You have to go through masses of regulations to offer your customers and distributors your products. It is inevitable. That is why when it comes to medical devices market regulatory strategy might be even more important than market strategy.

Regulatory compliance

To turn your strategy into action and place a medical device on a market you need to ensure regulatory compliance of your products. Regulatory compliance is your first step in winning a market. How you reach the compliance very much depends on type and class of your medical devices.

Regulatory affairs

While placing a medical device on a market you will have to go through regulations that are effective in this country and figure out a way its regulatory system works. It is possible you will have to communicate with national regulatory agencies or notified bodies. And your ability to effectively exchange information with the regulators will ensure your success. You can try to master tons of regulations yourself or you can get the work done by professionals.

PLACING YOUR MEDICAL DEVICES ON THE GLOBAL MARKETS

General strategy

If your goal is to bring a medical device to global markets you need a strategy. As most countries tightly regulate their medical devices markets, you will have to gain a lot of knowledge and a full understanding of your target market’s regulatory framework before you go for it.

Regulatory strategy

In the case of medical devices market the regulatory strategy is one of the most important parts of strategic planning. Market regulations pose the first hurdle a manufacturer must overcome to put their medical devices on a market. You have to go through masses of regulations to offer your customers and distributors your products. It is inevitable. That is why when it comes to medical devices market regulatory strategy might be even more important than market strategy.

Regulatory compliance

To turn your strategy into action and place a medical device on a market you need to ensure regulatory compliance of your products. Regulatory compliance is your first step in winning a market. How you reach the compliance very much depends on type and class of your medical devices.

Regulatory affairs

While placing a medical device on a market you will have to go through regulations that are effective in this country and figure out a way its regulatory system works. It is possible you will have to communicate with national regulatory agencies or notified bodies. And your ability to effectively exchange information with the regulators will ensure your success. You can try to master tons of regulations yourself or you can get the work done by professionals.

Five steps to ensure regulatory compliance

1. Medical device classification

Before you figure out how to move towards regulatory compliance you should get understanding what requirements will apply. In turns, requirements depend on risks associated with use of your medical device; and the risks determine the product’s class. That is why risk-based classification of medical devices is a critical step. This first step determines the nature of the following steps.

2. Creating technical documentation

The purpose of technical documentation is to convince the regulator of medical device’s safety, performance and quality. A regulator’s decision regarding your product often depends on whether your technical documentation is good enough.

3. Bringing your Quality Management System (QMS) into compliance with local regulations

Most regulatory agencies set strict requirements for medical device manufacturers’ quality systems. Making your QMS compliant with these requirements is essential to place a medical device on a market. Crucial components of manufacturers’ quality systems are the Risk Management System and Post Market Surveillance System.

4. Acquisition of clinical data

Most countries require including clinical data as a part of product dossier. Often such data can be collected during the Clinical Evaluation of your medical device. But sometimes clinical investigations must be conducted to obtain clinical evidence of device’s safety and performance.

5. Regulatory submission

The final step towards regulatory compliance is a regulatory submission followed by the regulator’s decision whether your medical device can be placed on the market. In some jurisdictions the low-risk classes of medical devices do not have to be scrutinized by the regulatory agencies before they are put on the market. However, they must conform to local regulations and may be subject to surprise inspections. Success of a regulatory submission depends upon the way in which the previous steps have been made.

MDRC assists medical device companies with regulatory approvals and placing medical devices on the European, USA and Latin American markets. We bring manufacturer’s technical documentation, QMS, post market surveillance and risk management systems into compliance with regulatory requirements of your strategic markets. Also, we assess whether your products require additional tests and studies and help organize them.

MDRC assists medical device companies with regulatory approvals and placing medical devices on the European, USA and Latin American markets. We bring manufacturer’s technical documentation, QMS, post market surveillance and risk management systems into compliance with regulatory requirements of your strategic markets. Also, we assess whether your products require additional tests and studies and help organize them.

We will help you gain access to your strategic markets

Implement your strategic plans together with MDRC

Send us an email at: info@mdrc-consulting.com

Or use the contact form      

Send us an email at: info@mdrc-consulting.com

Or use the contact form      

OUR PRINCIPLES

EXPERTISE

We are experts in our field. We have a broad and deep competence with regulatory affairs, technical documentation and quality systems. We find the best decisions and realize them for you.

QUALITY

We see the quality as a conformity between your goals and our results. Achieving your goals is the main quality criterion for our work.

TIMING

We know that your time is precious. Working with MDRC you will be sure that all tasks will be accomplished on time or even earlier.

LEAN THINKING

We practice lean office. We do not maintain redundant administrative activities and departments. That is why we can keep our prices so low.

RESULTS

We know that the customers pay us for results. Working with MDRC you can always count on excellence.

TRUST

Mutual trust is a basis for cooperation and we do everything to deserve our customers’ trust.

OUR PRINCIPLES

EXPERTISE

We are experts in our field. We have a broad and deep competence with regulatory affairs, technical documentation and quality systems. We find the best decisions and realize them for you.

QUALITY

We see the quality as a conformity between your goals and our results. Achieving your goals is the main quality criterion for our work.

TIMING

We know that your time is precious. Working with MDRC you will be sure that all tasks will be accomplished on time or even earlier.

LEAN THINKING

We practice lean office. We do not maintain redundant administrative activities and departments. That is why we can keep our prices so low.

RESULTS

We know that the customers pay us for results. Working with MDRC you can always count on excellence.

TRUST

Mutual trust is a basis for cooperation and we do everything to deserve our customers’ trust.

MDRC is a team of regulatory experts working for your company

Overcome all regulatory barriers together with MDRC - effectively, cost-efficiently, on time

12+

YEARS’ EXPERIENCE

200+

COMPLETED PROJECTS

100+

REGULATORY SUBMISSIONS

50+

NEW PRODUCTS

Your strategic markets: creating the regulatory strategy

There is no regulatory strategy that works for any company and any situation. We develop individual solutions for every customer depending on their goals, target markets as well as types and classes of their medical devices. We see the deep understanding of regulatory processes of your target market as a key to our common success.

There is no regulatory strategy that works for any company and any situation. We develop individual solutions for every customer depending on their goals, target markets as well as types and classes of their medical devices. We see the deep understanding of regulatory processes of your target market as a key to our common success.

EUROPE’S REGULATORY PROCESSES FOR MEDICAL DEVICES

USA REGULATORY PROCESSES FOR MEDICAL DEVICES

LATAM REGULATORY PROCESSES FOR MEDICAL DEVICES

RUSSIA’S REGULATORY PROCESSES FOR MEDICAL DEVICES

EUROPE’S REGULATORY PROCESSES FOR MEDICAL DEVICES

USA REGULATORY PROCESSES FOR MEDICAL DEVICES

LATAM REGULATORY PROCESSES FOR MEDICAL DEVICES

EUROPE’S REGULATORY PROCESSES FOR MEDICAL DEVICES

USA REGULATORY PROCESSES FOR MEDICAL DEVICES

LATAM REGULATORY PROCESSES FOR MEDICAL DEVICES

RUSSIA’S REGULATORY PROCESSES FOR MEDICAL DEVICES

CONTACT US

whether you have a question about our solutions or need help with your new project

    Contact us whether you have a question about our solutions or need help with your new project