Regulatory Affairs

MDI Adviser acts like an external regulatory affairs department for the sector companies and professionals, which allows the organization’s experts to not losing their time in foreign country regulatory affairs. From MDI Advisers we study the specific needs of any company to support you with the right solution.

Our regulatory affairs services are mainly aimed to medical products importers or distributers (with or without warehouse) which are regulated by the laws 93/42/ECC. Moreover, we offer  these services to any company or institution with these needs.frecer servicio a cualquier empresa o institución con estas necesidades.

regulatory affairs de productos sanitarios - chica

Regulatory Affairs

MDI Adviser acts like an external regulatory affairs department for the sector companies and professionals, which allows the organization’s experts to not losing their time in foreign country regulatory affairs. From MDI Advisers we study the specific needs of any company to support you with the right solution.

Our regulatory affairs services are mainly aimed to medical products importers or distributers (with or without warehouse) which are regulated by the laws 93/42/ECC. Moreover, we offer  these services to any company or institution with these needs.frecer servicio a cualquier empresa o institución con estas necesidades.

regulatory affairs de productos sanitarios - chica

Regulatory Affairs

regulatory affairs de productos sanitarios - chica

MDI Adviser acts like an external regulatory affairs department for the sector companies and professionals, which allows the organization’s experts to not losing their time in foreign country regulatory affairs. From MDI Advisers we study the specific needs of any company to support you with the right solution.

Our regulatory affairs services are mainly aimed to medical products importers or distributers (with or without warehouse) which are regulated by the laws 93/42/ECC. Moreover, we offer  these services to any company or institution with these needs.frecer servicio a cualquier empresa o institución con estas necesidades.

Regulatory Affairs de productos sanitarios - grupos

What is our regulatory affairs department and what they do?

The main objective of the department is achieve that pharmacological products  gain acces to the market. Our department works hand-to-hand with the other departments of the organization to achieve that the products that are comercialized reach the market under all the sanitary guaarantees and in the shortest possible timelapse.

There are many types of products in the market, with different characteristics  and peculiarities. This implies that their needs in order to be comercialized are different. Those needs are responsible for the products to be safe, as no medicine can be sold without the consentment of the sanitary authorities.

To show that a product can be marketed, this has to be safe, effective and high-quality. Moreover, once it is already marketed, new regulatory needs can appear due to either a change in the law or a change in the product.

What is our regulatory affairs department and what they do?

Regulatory Affairs de productos sanitarios - grupos

The main objective of the department is achieve that pharmacological products  gain acces to the market. Our department works hand-to-hand with the other departments of the organization to achieve that the products that are comercialized reach the market under all the sanitary guaarantees and in the shortest possible timelapse.

There are many types of products in the market, with different characteristics  and peculiarities. This implies that their needs in order to be comercialized are different. Those needs are responsible for the products to be safe, as no medicine can be sold without the consentment of the sanitary authorities.

To show that a product can be marketed, this has to be safe, effective and high-quality. Moreover, once it is already marketed, new regulatory needs can appear due to either a change in the law or a change in the product.

What is our regulatory affairs department and what they do?

The main objective of the department is achieve that pharmacological products  gain acces to the market. Our department works hand-to-hand with the other departments of the organization to achieve that the products that are comercialized reach the market under all the sanitary guaarantees and in the shortest possible timelapse.

Regulatory Affairs de productos sanitarios - grupos

There are many types of products in the market, with different characteristics  and peculiarities. This implies that their needs in order to be comercialized are different.

Those needs are responsible for the products to be safe, as no medicine can be sold without the consentment of the sanitary authorities.

To show that a product can be marketed, this has to be safe, effective and high-quality. Moreover, once it is already marketed, new regulatory needs can appear due to either a change in the law or a change in the product.

How does our regulatory affairs service in Madrid works?

From our offices in Madrid , Spain, we offer our services to all the country and Portugal. To do so, we assign a licensed pharmacy who will act as technical responsible of your company and will manage the files with the administration in order with the present law. If your company already has a technic that needs our help for any reason, MDI offers punctual solutions at a very competitive prize to face the taks to be done.

With our sanitary patent regulator service, we manage to maintain a permanent contact with the appropiatedepartments of your company, constantly checking the succesful fulfillment of the law.

Regulatory Affairs de productos sanitarios - centrifugadora

How does our regulatory affairs service in Madrid works?

From our offices in Madrid , Spain, we offer our services to all the country and Portugal. To do so, we assign a licensed pharmacy who will act as technical responsible of your company and will manage the files with the administration in order with the present law. If your company already has a technic that needs our help for any reason, MDI offers punctual solutions at a very competitive prize to face the taks to be done.

Regulatory Affairs de productos sanitarios - centrifugadora

With our sanitary patent regulator service, we manage to maintain a permanent contact with the appropiatedepartments of your company, constantly checking the succesful fulfillment of the law.

How does our regulatory affairs service in Madrid works?

Regulatory Affairs de productos sanitarios - centrifugadora

From our offices in Madrid , Spain, we offer our services to all the country and Portugal. To do so, we assign a licensed pharmacy who will act as technical responsible of your company and will manage the files with the administration in order with the present law. If your company already has a technic that needs our help for any reason, MDI offers punctual solutions at a very competitive prize to face the taks to be done.

With our sanitary patent regulator service, we manage to maintain a permanent contact with the appropiatedepartments of your company, constantly checking the succesful fulfillment of the law.

Regulatory Affairs de productos sanitarios - compromiso

What does MDI Advisers offer to your organization in the field of Regulatory Affairs?

It is important to bear in mind that MDI Advisers in regard to Regulatory Affairs, Regulatory Affairs or Health Registries only works with Health Products or Medical Devices (M.D.), as they are known in the jargon of the Health Technology Industry.

In order for a medical device to be marketed in Spain or Portugal, it is necessary that it has previously obtained the CE mark with a Notified Body established in the EU and requests the registration of it with the competent national authorities. This is: Spanish Agency of Medicines and Health Products (AEMPS) in Spain or National Institute of Pharmacy and Medicine (INFARMED) in Portugal.

MDI Advisers puts at your disposal a professional who will act as interlocutor before the health authorities, carrying out the necessary administrative procedures for the communication of placing on the market of medical devices.

What kind of client may need our help? We provide value to distributors and importers with and without warehouse that market or want to market finished products that have all the necessary certificates for their placing on the market and especially the CE mark.

What does MDI Advisers offer to your organization in the field of Regulatory Affairs?

Regulatory Affairs de productos sanitarios - compromiso

It is important to bear in mind that MDI Advisers in regard to Regulatory Affairs, Regulatory Affairs or Health Registries only works with Health Products or Medical Devices (M.D.), as they are known in the jargon of the Health Technology Industry.

In order for a medical device to be marketed in Spain or Portugal, it is necessary that it has previously obtained the CE mark with a Notified Body established in the EU and requests the registration of it with the competent national authorities. This is: Spanish Agency of Medicines and Health Products (AEMPS) in Spain or National Institute of Pharmacy and Medicine (INFARMED) in Portugal.

What kind of client may need our help? We provide value to distributors and importers with and without warehouse that market or want to market finished products that have all the necessary certificates for their placing on the market and especially the CE mark.

MDI Advisers puts at your disposal a professional who will act as interlocutor before the health authorities, carrying out the necessary administrative procedures for the communication of placing on the market of medical devices.

What does MDI Advisers offer to your organization in the field of Regulatory Affairs?

Regulatory Affairs de productos sanitarios - compromiso

It is important to bear in mind that MDI Advisers in regard to Regulatory Affairs, Regulatory Affairs or Health Registries only works with Health Products or Medical Devices (M.D.), as they are known in the jargon of the Health Technology Industry. In order for a medical device to be marketed in Spain or Portugal, it is necessary that it has previously obtained the CE mark with a Notified Body established in the EU and requests the registration of it with the competent national authorities. This is: Spanish Agency of Medicines and Health Products (AEMPS) in Spain or National Institute of Pharmacy and Medicine (INFARMED) in Portugal.

What kind of client may need our help? We provide value to distributors and importers with and without warehouse that market or want to market finished products that have all the necessary certificates for their placing on the market and especially the CE mark.

MDI Advisers puts at your disposal a professional who will act as interlocutor before the health authorities, carrying out the necessary administrative procedures for the communication of placing on the market of medical devices.

Do you have any questions?

In MDI adviser we put at your service the professional team you need!

Sanitary patent registration in Spain and Portugal.

Although our operation center is in Madrid, MDI advisers offers service in all national territory and Portugal. If your company wants to access either spanish or portuguese market, independently of the origin, please send an email to info@mdiadvisers.es specifying your contact information.

MDI Adviser is the best ally that your company can have in regulatory affairs. Our profesional history, direct and continued contact with the companies and the speed are the key for success. In MDI advisers we work to offer the best solution to each of our customers, guaranteeing proficiency in all the issues.

Regulatory Affairs de productos sanitarios - sevicios

Sanitary patent registration in Spain and Portugal.

Although our operation center is in Madrid, MDI advisers offers service in all national territory and Portugal. If your company wants to access either spanish or portuguese market, independently of the origin, please send an email to info@mdiadvisers.es specifying your contact information.

MDI Adviser is the best ally that your company can have in regulatory affairs. Our profesional history, direct and continued contact with the companies and the speed are the key for success. In MDI advisers we work to offer the best solution to each of our customers, guaranteeing proficiency in all the issues.

Regulatory Affairs de productos sanitarios - sevicios
Regulatory Affairs de productos sanitarios - oficina

Sanitary patent registration

If you want to ask for more information or ask for a budget to register a patent of a sanitary product in Madrid or regulation of sanitary products, contact with us in the phone +34 910 05 98 28 or write an email to info@mdiadvisers.es. In MDI advisers we will arrange a meeting in our central office or in the customer office in Madrid, which will be the starting point to study and find the needs of each company

Sanitary patent registration

If you want to ask for more information or ask for a budget to register a patent of a sanitary product in Madrid or regulation of sanitary products, contact with us in the phone +34 910 05 98 28 or write an email to info@mdiadvisers.es. In MDI advisers we will arrange a meeting in our central office or in the customer office in Madrid, which will be the starting point to study and find the needs of each company

Regulatory Affairs de productos sanitarios - oficina

Sanitary patent registration

Regulatory Affairs de productos sanitarios - oficina

If you want to ask for more information or ask for a budget to register a patent of a sanitary product in Madrid or regulation of sanitary products, contact with us in the phone +34 910 05 98 28 or write an email to info@mdiadvisers.es. In MDI advisers we will arrange a meeting in our central office or in the customer office in Madrid, which will be the starting point to study and find the needs of each company