Consulting in biomedical field

The consulting service in Studio Ambiente has been carried out for years with the collaboration of a team of professionals such as biologists, biomedical engineers, pharmaceutical chemists and biotechnologists with acquired and proven experience. Over time Studio Ambiente has focused its consulting activity specifically in the field of Medical Devices, specializing in the preparation of Quality Management Systems, in the drafting of Technical Files and in the practices necessary for the marketing of Medical Devices in different World Markets (Europe, U.S.A. – FDA, Canada – HEALTH CANADA, Brazil – ANVISA).

Currently the consulting activities are focused on on-site and remote assistance for product certifications such as CE Marking of Medical Devices, Registration of Medical Devices for the U.S. Market, through 510(k) FDA practices, Registration of Medical Devices for the Canadian Market and company certifications according to the applicable standards of the Quality Management System, ISO 13485 and ISO 9001.

Recently, the Consulting Service has expanded its expertise and activities to support Medical Device Manufacturers also for MDSAP certifications required for markets outside the EU such as USA, CANADA, BRAZIL, JAPAN and AUSTRALIA.

OUR MISSION

Studio Ambiente is today the ideal partner to address in order to achieve the goal of marketing your medical devices in several world markets.

The experience gained over the years, professionalism, specific skills and internal organization allow us to assist our customers at 360 degrees, identifying the fastest and cheapest regulatory strategies in order to market a Medical Device.

All this thanks to the passion that is spent every day in our professional activity, in the complete availability to the customer and in the excellent problem-solving skills that have been developed over the years.

Our motto is “Strategies for quality in biomedical field” for this Studio Ambiente is the ideal partner in the research of the best strategy to get to the commercialization of your medical device in the shortest time possible.

OUR TEAM

Over the years Studio Ambiente has built up a team of consultants who, with their professionalism and passion, make their know-how available to companies every day to define the most appropriate regulatory strategies and to achieve the goals set by their customers.

The Team of Consultants in Studio Ambiente is made up of different professional figures and consists to date of biologists, biomedical engineers, pharmaceutical chemists and biotechnologists. This interdisciplinarity is now the strength of the Consulting Team because the synergy of different specializations allows to perform a 360° analysis of products and consequently allows the identification of the most appropriate regulatory strategy. Moreover, a continuous updating of the Consulting Team over the years has allowed to develop high skills in the field of medical devices and specifically for the following types of products:

Non-active medical devices for wound care;
Non-Active Medical Devices for Injection, Infusion, Transfusion and Dialysis;
Non-Active Medical Devices for Disinfection of Medical Devices;
Non-Active Medical Devices for Irrigation and Washing;
Non-Active Medical Devices for Ingestion;
Non-Active Medical Devices for Ophthalmic Use;
Implantable Non-Active Medical Devices for Aesthetic Medicine and Orthopaedics;
Implantable Non-Active Medical Devices;
Non-active Medical Devices – Suture Materials;
Non-active Medical Devices containing Medicinal Substances;
Non-Active Medical Devices that include tissues of animal origin;
Active Medical Devices for Cardiology;
Active Medical Devices for Neurosurgery;
Active Medical Devices for Surgery;
Active Medical Devices incorporating Software;

MEDICAL DEVICES CE MARKING

(Directive 93/42/EEC and EU Regulation 2017/745)

The process of CE Marking of a Medical Device is carried out in Studio Ambiente through the consulting activity that provides for the Client:

Analysis of product information and regulatory framework with identification of the device risk classification;
Identification of the regulatory strategies necessary to obtain the Medical Device CE Mark;
Identification of the Notified Body suitable for obtaining the Medical Device CE Mark;
Identification and analysis of the laws and technical standards applicable to the Medical Device;
Identification and implementation of technical product analyses necessary to obtain the CE marking of the Medical Device (e.g. Biocompatibility, Validation of the Sterile Barrier, Sterilization);
Drafting of the CE Mark Technical File;
Drafting of the Project Dossier necessary for the CE Marking of Class III Medical Devices;
Drafting of the Risk Analysis in accordance with ISO 14971, which includes Risk/Benefit Analysis;
Drafting of the Clinical Evaluation Report (CER) in compliance with MEDDEV 2.7/1 current edition.
Drafting of a specific Post Market Surveillance (PMS) and Post Market Clinical Follow Up (PMCF) Plan for the Medical Device in compliance with MEDDEV 2.12-1 and MEDDEV 2.7-2 current edition.

In support of the CE Marking process Studio Ambiente can produce specific technical documentation such as:

Biological Risk Assessment (BRA) to demonstrate the Biocompatibility of a Medical Device according to ISO 10993-1;
Specific dossiers for Class III Medical Devices incorporating ancillary medicinal or pharmaceutical substances or animal origin derivatives;
Gap Analysis and identification of the correct regulatory procedure for Medical Devices to be recertified according to the new EU Regulation 2017/745;
Support to the implementation of an UDI (Unic Device Identifier) coding system according to the new EU Regulation 2017/745;

OTHER SERVICES RELATED TO THE BIOMEDICAL SECTOR

European Representative for companies manufacturing medical devices not located in the EU as required by MEDDEV 2.5/10;
Assistance in the management of the medical device surveillance system in Europe as provided for in MEDDEV 2.12/1;
Assistance in the preparation of documents and in the request for obtaining the of free sale certificate (FSC) at the competent Italian Authority;
Assistance in the registration procedure in the Italian Ministry of Health database of medical devices for Italian and foreign companies.

US FDA 510(k) PREMARKET NOTIFICATION

The registration process of a Medical Device in the U.S. Market is carried out in Studio Ambiente through the consulting activity that include:

Feasibility analysis for the preparation of the U.S. FDA 510(K) premarket notification file;
Identification of the Regulatory Strategies necessary to obtain the Market Clearance of the Medical Device;
Drafting of 510(k) files for placing the Medical Device on the market;
Delivery of 510(k) files and assistance until obtaining FDA Market Clearance;
Assistance for the company registration in the FDA FURLS SYSTEM necessary for the Establishment Registration in case of first placing on the American market.

QUALITY MANAGEMENT SYSTEM

Studio Ambiente, through its consulting activity, is able to support device manufacturers and distributors in the implementation and adaptation of a Quality Management Systems through:

Preparation of quality management systems based on the needs of the customer;
Drafting of quality management systems in compliance with ISO 9001;
Drafting of quality management systems in compliance with ISO 13485;
Adaptations of quality management systems from ISO 9001 to ISO 13485;
Adaptations of quality management systems in compliance with non-EU regulations such as USA, CANADA, BRAZIL, JAPAN and AUSTRALIA, supporting the customer in the preparation of the system in accordance with the requirements of MDSAP Certification;
Internal audits to verify the conformity of the quality management system in compliance with the ISO 9001 standard conducted by experienced and qualified auditors;
Internal audits to verify the conformity of the quality management system in accordance with ISO 13485 conducted by experienced and qualified auditors;
Internal audits to verify the compliance of the quality management system with the Extra-EU Regulations such as USA, CANADA, BRAZIL, JAPAN and AUSTRALIA, conducted by experienced and qualified auditors;
Audits of Suppliers of Medical Device Manufacturers to verify the compliance of the quality management system with ISO 13485 or Directive 93/42/EEC and subsequent amendments, conducted by experienced and qualified auditors;
Assistance during audits by Notified Bodies, Certification Bodies and Competent Authorities.