GUIDE
How you can safely choose
a good manufacturer
of health and orthopaedic products

These are the 7 key aspects to be considered in order to avoid errors when selecting a manufacturer of health and orthopaedic products


Orthopaedics is a rapidly growing industry and one that promises to continue this growth. Advances in technology and the influence of technology on this industry have helped it to progress at a faster rate than that achieved in the last 10 years. This means that there will be new products and orthopaedic technologies that emerge again and again.

The distribution of orthopaedic and health products is a lucrative field, but it is also a highly technical one where product selection can play an important role in the success of a new operation. When selecting the correct manufacturer, several factors must be considered.

1. Know exactly what I need

Knowing about the most highly demanded orthopaedic and health products is extremely important for a company, as it allows them to know what products to offer, which ones to manufacture, and which ones to keep in stock.

It is useful to start with a product that has become standard in the sector. This ensures that the money spent is well-invested.

To have a good understand of potential clients is vital, since ignorance of users’ requirements makes it complicated to know how to satisfy their needs. Thus, the first thing to do  in order to understand users’ requirements is to conduct a market survey. To see what the market wants, what it offers, and what it is willing to pay for it.

2. Who is the final stage manufacturer and what guarantees do they offer?

The manufacturer must be trustworthy, serious and have sufficient experience that guarantees the purchase.

The current reality however is far from being perfect, as the high demand for orthopaedic products has led to the appearance of dishonest manufacturers who only work on the visual appearance of the product and not its quality, to make sales.

There are many companies that prosper in this industry because they continue to improve their technology and innovation, thus helping to create better and more effective orthopaedic products.

Good manufacturers of orthopaedic products offer reliable and good quality products and services that guarantee the physical wellbeing of users. They ensure that their products are designed and built with the latest technology and manufactured in an ergonomic environment that protects the workers’ and users’ health.

The physical and chemical properties and the pharmaceutical characteristics of the raw materials used in manufacturing orthopaedic and health products must be assessed and checked to ensure that they are suitable for the intended use of the end product.

The provider of orthopaedic products must guarantee that they fulfil all health regulations, product compliance and facilitate communication in case of product withdrawal. Additionally, it is the responsibility of the manufacturer of orthopaedic and health products to conduct all necessary tests to ensure that the product complies with all safety regulations.

Quality assurance in the manufacturing of orthopaedic products is the company’s commitment to people’s health, with the fulfilment of the highest quality standards and the continuous improvement of their products, services and processes.

The manufacturer of orthopaedic products must be able to guarantee that the orthopaedic products are manufactured in a clean environment and does not contain any element that may cause any diseases.

The manufacturers of orthopaedic products must also guarantee that their products are not in a poor physical state and may be safely used.

Another thing to be considered is tracing the final stage manufacturer. There are many providers that do not directly manufacture their products. The ability to contact the final stage manufacturer always ensures improved costs, better profit margins for the company, the safety of not having to deal with intermediaries, better production deadlines and periods of time.

To sum up, the manufacturers of orthopaedic products must fulfil three guarantees: first, they must offer health products that are safe and effective. Secondly, they must comply with the health and safety regulations of the countries where they are sold. Finally, this information must be clearly communicated to the seller.

3. Do I have the possibility of custom-made designs?

When you buy a pair of shoes, you want it to fit properly, right? When buying an orthopaedic product, can you imagine how frustrating it would be to receive it only to discover that it does not fit your needs or those of your customer?

In order to find orthopaedic products that adjust to each patient, it is important that the manufacturer of these products can adapt them. The manufacturer should be able to build the requested product, even if it has to be tailor-made and from a new set of blueprints.

This flexibility to adjust to the client’s needs marks the difference between a good provider of orthopaedic and health products and those that are probably not equipped to deal with the demands of the market.

4. Is it certified and does it comply with the current legislation?

Fulfilling all the requirements set by the current regulations, by means of the applicable certificates, is logically essential.

These are the general requirements for manufacturers of custom-made health products:

1. To have an organisational structure that is able to guarantee product quality and the execution of all appropriate procedures and controls.

2. The availability of suitable establishments, procedures, equipment and personnel, in line with the relevant activities and products.

3. The availability of a responsible technician, with certified suitable training for the products they handle, who will directly supervise the company activity

Source: https://www.boe.es/eli/es/rd/2002/05/10/437

The legislation on health products has been amended in recent years due to the new directives that regulate these products within the European Union. These directives have been transposed into Spanish law by means of the following Royal Decrees that also establish the conditions for undertaking certain strictly domestic activities: manufacture, distribution, sale, adaptation of health products and advertising.

Source: https://www.mscbs.gob.es/profesionales/farmacia/legislacion/prodSanitarios/cir_21_97.htm

In addition to these requirements, it must be considered whether the manufacturer possesses ISO certification of their manufacturing quality.

For more information, consult these links:

https://www.aenor.com/certificacion/quimico-farmaceutico-y-cosmetico/productos-sanitarios

The UNE is the only Standards Body in Spain, appointed by the Ministry of Economy:

ISO database in the official website of UNE.org. (It is possible to search by ISO type)

Other sources of interest:

Real Decreto 1591/2009, de 16 de octubre, por el que se regulan los productos sanitarios

Real Decreto 437/2002, de 10 de mayo, por el que se establecen los criterios para la concesión de licencias de funcionamiento a los fabricantes de productos sanitarios a medida

Información sobre el marcado CE de la Unión Europea

Base de datos de Ceapat- Imserso sobre normativa Española y Europea

5. Is the quality of the product consistent with the health purpose for which it is intended?

Product quality must be as high as possible, given its ultimate health goal. This quality also includes the finish and raw materials. In this regard, we once again point to the information provided above.

The quality that is promised and that which is later received must be in line with the legal and contractual provisions.

Having a few samples may help you to decide whether the quality is suited to your needs or not. You may ask the manufacturer for samples. While not usually a problem, this will however depend on each manufacturer’s policy.

Whenever possible, it is worth paying a visit to the company providing the health and orthopaedic products, in order to check the quality of their products first-hand.

6. Can you give me a reference of other clients with whom you work?

A list of current clients provided by the manufacturing company is useful when ensuring that it is a top-tier manufacturer.

Normally, companies that manufacture health and orthopaedic products tend to provide the names of a few clients who are regular buyers of their products, usually listed on their websites.

If this is not the case, they may always be asked for references and it may even be a good idea to contact these clients directly to ask for their opinion of the provider in question.

Not all companies will be willing to provide this information, often not because they don’t want to, but because it would violate confidentiality clauses that they have signed with their clients.

It’s a good idea to ask for references, but it’s not something that is always available.

7. Are they responsible with regard to deliveries and deadlines?

Complying with the previously established deadlines for delivering the purchased product is a basic requirement in any deal, but the manufacturer’s strict adherence to its fulfilment is not always a given. There are always variables that may complicate delivery deadlines, sometimes it is the client’s fault and sometimes, the provider’s.

The best way to ensure deadlines is to put down clauses on fulfilment and the responsibilities of both parties, when drawing up the contract. This, along with the references to other satisfied clients, as previously mentioned, may make the difference between a smooth experience and one with last-minute disagreeable surprises.

To sum up:

  • Understand and be clear about the types of products to be marketed, in order to find the provider best suited to your needs.
  • Careful when dealing with intermediaries, always deal directly with the final stage manufacturer whenever possible. This will save production costs and time.
  • Always ensure that the certifications and the products fulfil the necessary guarantees and those that are required by law.
  • The ability to personalise and adjust products to your needs is a point in favour of the company that makes it possible.
  • Obtain references of other company clients whenever possible.
  • All necessary details should be included in the contract. Fulfilling deadlines is a basic requirement but one that is not always complied with. Finding a company that is responsible in this regard is crucial.

Discover why many of our clients have chosen Sumisalud as their trustworthy supplier of health and orthopaedic products for years.

The best hospitals and distributors in this sector have placed their trust in us.

operaria en las fábricas de BioreVic Sumisalud


BioreVic helped us create a product that is unique in the market

“For us, BioreVic was a leap in quality as it allowed us to tailor-make a product that is unique in the market. They made it a reality”.
Antonio Pérez Corvera
BioPharmed Ibérica


It’s a pleasure to have domestic providers like BioreVic

“They’ve given us a series of high-quality Brand Spain products, at very good prices and always according to our specifications and regulations.
Dioni Nespral
Ortones


With BioreVic, new business ventures are always something to look forward to

“We’ve known each other for a long time. You know they’re going to be there, they’ll respond and deliver accordingly and on time. Highly recommended”.
Juan Carlos Calle
Mafarhos


BioreVic products are among the bestselling products in our catalog.

“If there are new market trends, they come up with prototypes and once we put them up for sale, they’re highly in demand. BioreVic is a sign of sure success for us”.
Jaime González
Ortoprime

Clients who trust BioreVic Sumisalud