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Improve Product Compliance with SPK

Your team deserves guidance from consultants that have been there and done that.

A recent study showed that 53% of CEOs from global life sciences companies consider regulations to be a top disruptive trend.  That disruption is seen in additional costs, time delays to get products to market, and missed opportunities.  Because SPK is involved in helping get our client’s products to market, we know how to optimize processes and procedures to limit the time it takes to remain compliant, but quickly get your products to market.  

We Work with Companies Big and Small.  We Can Help You Too!

SPK’s team has over 20 years of expertise working with organizations that range from globally recognized brands to small, family-owned companies. Start-ups and established multinationals choose SPK as their partner to achieve and maintain compliance with global standards & regulations. This positions us to provide unique insights that you can’t find anywhere else.  We can help design your processes or systems to make it easier for your company to be compliant.

 

Industries & Standards

Medical Device

  • ISO 13485:2016
  • MDSAP – Med Device Single Audit Program
  • US FDA 21 CFR Part 820
  • US FDA 21 CFR Part 11
  • European MDD / AIMDD / IVDD
  • New EU MDR / AIMDR / IVDR
  • Health Canada CMDR
  • ISO 14971 Risk Management
  • IEC 60601 Electrical Equipment

Automotive

  • ISO 26262-1:2018
  • IATF 16949:2016
  • AIAG Core Tools (APQP, PPAP, FMEA, MSA, and SPC)
  • VDA

Quality Management

  • ISO 9001:2015
  • ISO 17025 Testing & Calibration
  • ISO 17100 Translation Services
  • API Spec Q1
  • ISO/IEC 80079-34
  • Food Safety (GFSI, BRC, SQF, IFS, FSSC/ISO 22000, 21 CFR Part 110, etc.)

Aerospace

  • AS9100 Rev. D
  • AS9110
  • AS9120
  • NADCAP

GxP

  • GMP (Good Manufacturing Practice)
  • GLP (Good Laboratory Practice)
  • GDP (Good Distribution Practice)
  • GCP (Good Clinical Practice)

What our clients say

Their talent is top notch and augments and deepens our engineering capabilities in technical areas where we lack expertise and cannot add dedicated personnel. 

Ramanan P.

Leading Medical Device Manu.

Working with SPK feels like working with co-workers in my company, not like interacting with a typical technical support vendor. SPK staff are responsive and partner with me.

Jay DiToro

Ximedica

The personalized attention and detailed communication we receive working with SPK and Associates is pretty special. The accessibility of SPK team members is impressive...

Evan B.

Leading Medical Device Manu.

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