It ‘necessary to show that there is full control over all life cycle of a product starting from the ideation, the definition of constraints and specifications, the choice of the design, the production process.

It ‘important to confirm that in all these phases a repeatable method  has been used and demonstrate through records, documentation, procedures.

The choice of the validation procedure, the tests for the validation and related acceptance criteria must be defined based on reference standards and optimized according to the characteristics of the product or process that you want to validate.

We support the validation and the establishment of quality systems with particular reference to the medical device sector, with reference to ISO and GMP standards.

Validate means

“Providing an evidence documented by ensuring, with a high degree of safety, that a specific process (or subprocess) is able to make in a repeatable way a product that meets the specifications recorded and the quality standards predetermined”

We perform validation of following processes

• Injection Molding
• Pharmaceutical Packaging
• 3D Printing
• CNC Milling
• Clean rooms
• Sterilization processes
• Cleaning Processes
• Heating treatments
• Coating Treatments

1. CLASSIFICATION (CHAPTER V)

• Check new classification rules (MDR Classes I, IIa, IIb and III) (Art. 51, Annex VIII) (eg. Surg mesh, software,etc…)
• Check the new definition of MDR, particularly with respect to its expanded scope. This also applies to products covered in (Art. 1, 2, Annex XVI) (eg. Cleaning device, Contact lens, liposuction, skin treatment…)
• Special Device (Art. 21) (investigation dev., etc..)

2. CONFORMITY ASSESSMENT (CHAPTER V)

• Confirm conformity assessment routes for existing and future products (Art. 52, Annex IX, X, XI) (eg. Class Ir..)

3. CHECK NOTIFIED BODY STATUS

4. REVIEW QMS AND TECHFILE

QMS

• Review and upgrade quality management system (QMS) (eg. Art. 10 (9))
• Assess impact on products, internal resources, organisation and budget, ex. Person responsible for regulatory compliance (Art. 15)

TECH FILE

• Review the changes needed to existing technical documentation (Annex II)
• Tech file conservation period (min. 10 yr after last device placed on the market Art.10 (8))

5. PERFORM PMS (Chapter VII) and CLINICAL EVALUATION AND INVESTIGATION (Chapter VI) GAP ASSESSMENT

6. EVALUATE NEW UDI AND TRACEABILITY REQUIREMENTS

EUDAMED/UDI AND TRACEABILITY

• Ensure the respect of traceability obligations UDI/EUDAMED (Chapter III)
• Information to be provided upon registration (Annex VI)

LABELLING

• Review product labelling (Annex I ,Chapter III))
• Implant card and information to be supplied to the patient with an implanted device (Art. 18)